Trial Outcomes & Findings for Mechanical vs. Radiofrequency-Based Debridement in the Treatment of Articular Cartilage Lesions (NCT NCT01803880)
NCT ID: NCT01803880
Last Updated: 2019-03-28
Results Overview
The scores of 5 subscales of KOOS (i.e., Pain, other Symptoms, Function in daily living \[ADL\], Function in Sport and Recreation \[Sport/Rec\] and knee related Quality of Life \[QoL\]) at Baseline, Week 52 and change from Baseline were summarized descriptively by treatment group. The average of KOOS subscale scores was considered as the primary endpoint. For any subject if the value of effectiveness parameter was missing at Week 52 then it was imputed by last observed post-Baseline value (LOCF method). Each subscale response is based on a 5-point Likert system with each response score ranging from 0 (no problems) to 4 (extreme problems). Each subscale score is calculated independently. A score of 100 indicated no problems and a score of 0 indicated extreme problems. KOOS subscale score = 100 - (mean of the observed items within the subscale x100 / 4)
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
148 participants
Primary outcome timeframe
Postop Week 52
Results posted on
2019-03-28
Participant Flow
There were 148 subjects who initially signed a consent form, although 72 subjects withdrew consent prior to starting the study. This resulted in only 76 subjects actually starting the study and proceeding with study treatment.
Part I required all qualified investigators to perform 1 to 3 procedures using the study devices for the purpose of minimizing variability with the recommended directions for use established in the instructions for use. Part I subjects were to be included in the safety population only.
Participant milestones
| Measure |
Part I
Part I: All Investigators were required to perform 1 to 3 procedures using the study device to minimize variability relating to the technique recommended in the IFU. These subjects were followed per protocol and analyzed for safety findings only.
|
Part II: RF-based Debridement
Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
|
Part II: Mechanical Debridement
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
28
|
29
|
|
Overall Study
COMPLETED
|
13
|
18
|
14
|
|
Overall Study
NOT COMPLETED
|
6
|
10
|
15
|
Reasons for withdrawal
| Measure |
Part I
Part I: All Investigators were required to perform 1 to 3 procedures using the study device to minimize variability relating to the technique recommended in the IFU. These subjects were followed per protocol and analyzed for safety findings only.
|
Part II: RF-based Debridement
Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
|
Part II: Mechanical Debridement
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
4
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Unable to return for follow-up visits
|
0
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Early study termination
|
0
|
6
|
5
|
|
Overall Study
Incomplete data entry by sites
|
2
|
0
|
0
|
Baseline Characteristics
Mechanical vs. Radiofrequency-Based Debridement in the Treatment of Articular Cartilage Lesions
Baseline characteristics by cohort
| Measure |
Part I
n=19 Participants
Part I: All Investigators were required to perform 1 to 3 procedures using the study device to minimize variability relating to the technique recommended in the IFU. These subjects were followed per protocol and analyzed for safety findings only.
|
Part II: RF-based Debridement
n=28 Participants
Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
|
Part II: Mechanical Debridement
n=29 Participants
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 8.15 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 7.22 • n=7 Participants
|
58.0 years
STANDARD_DEVIATION 9.76 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 8.68 • n=4 Participants
|
|
Age, Customized
Age of Subjects · <40 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Customized
Age of Subjects · ≥40 years
|
18 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
BMI
|
28.4 kg/m^2
STANDARD_DEVIATION 3.02 • n=5 Participants
|
29.9 kg/m^2
STANDARD_DEVIATION 3.41 • n=7 Participants
|
29.0 kg/m^2
STANDARD_DEVIATION 4.02 • n=5 Participants
|
29.2 kg/m^2
STANDARD_DEVIATION 3.57 • n=4 Participants
|
|
Total pre-debridement lesion size
≤2 cm^2
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Total pre-debridement lesion size
>2-4 cm^2
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Total pre-debridement lesion size
Missing
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Duration (days) since onset of symptoms for index knee
Acute: ≤30 days
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Duration (days) since onset of symptoms for index knee
Subacute: 31 days - 6 months
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Duration (days) since onset of symptoms for index knee
Chronic: >6 months
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Duration (days) since onset of symptoms for index knee
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Knee Alignment
Varus malalignment
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Knee Alignment
Valgus malalignment
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Knee Alignment
Normal
|
18 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Narrowest width of meniscal rim post-operatively (radial measurement of meniscus post resection)
0 - 3º
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Narrowest width of meniscal rim post-operatively (radial measurement of meniscus post resection)
>3º
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Narrowest width of meniscal rim post-operatively (radial measurement of meniscus post resection)
Missing
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Postop Week 52Population: ITT Population
The scores of 5 subscales of KOOS (i.e., Pain, other Symptoms, Function in daily living \[ADL\], Function in Sport and Recreation \[Sport/Rec\] and knee related Quality of Life \[QoL\]) at Baseline, Week 52 and change from Baseline were summarized descriptively by treatment group. The average of KOOS subscale scores was considered as the primary endpoint. For any subject if the value of effectiveness parameter was missing at Week 52 then it was imputed by last observed post-Baseline value (LOCF method). Each subscale response is based on a 5-point Likert system with each response score ranging from 0 (no problems) to 4 (extreme problems). Each subscale score is calculated independently. A score of 100 indicated no problems and a score of 0 indicated extreme problems. KOOS subscale score = 100 - (mean of the observed items within the subscale x100 / 4)
Outcome measures
| Measure |
Part II: RF-based Debridement
n=28 Participants
Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
|
Part II: Mechanical Debridement
n=28 Participants
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
Part II: Mechanical Debridement
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
|---|---|---|---|
|
Change From Baseline in Knee and Osteoarthritis Outcomes Scores (KOOS) at Week 52 Post-operative
|
31.94 score on a scale
Standard Error 3.991
|
39.36 score on a scale
Standard Error 4.210
|
—
|
SECONDARY outcome
Timeframe: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/Early Termination (ET)Population: Not all participants completed the IKDC score questionnaires.
The scores of three domains of IKDC Subjective Knee Evaluation Form (i.e., \[1\] symptoms, including pain, stiffness, swelling, locking/catching, and giving way; \[2\] sports and daily activities; and \[3\] current knee function) at Baseline, each of scheduled post-operative visits and changes from Baseline were summarized descriptively by treatment group. Change from Baseline in IKDC = IKDC at Baseline + Pseudo-site + Treatment + Treatment\*Pseudo-site The IKDC score was interpreted by summing the scores for the individual questions and then transforming the score to a scale that ranged from 0 to 100: Individual domain IKDC score = \[raw score - lowest possible score/range of scores\] x 100 The IKDC total score was interpreted as higher scores = higher function, lower scores = lower function. Treatment\*Pseudo-site interaction term was non-significant at the 0.05 level and hence was dropped from the statistical method.
Outcome measures
| Measure |
Part II: RF-based Debridement
n=28 Participants
Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
|
Part II: Mechanical Debridement
n=29 Participants
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
Part II: Mechanical Debridement
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
|---|---|---|---|
|
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline.
Week 12 (Change from Baseline)
|
30.6 score on a scale
Standard Deviation 19.57
|
33.1 score on a scale
Standard Deviation 20.55
|
—
|
|
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline.
IKDC Summary Total Scores (Baseline)
|
39.4 score on a scale
Standard Deviation 14.56
|
37.3 score on a scale
Standard Deviation 14.40
|
—
|
|
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline.
Week 6
|
60.7 score on a scale
Standard Deviation 15.42
|
64.4 score on a scale
Standard Deviation 16.39
|
—
|
|
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline.
Week 6 (Change from Baseline)
|
21.0 score on a scale
Standard Deviation 13.30
|
27.0 score on a scale
Standard Deviation 22.17
|
—
|
|
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline.
Week 12
|
69.8 score on a scale
Standard Deviation 20.63
|
70.3 score on a scale
Standard Deviation 20.24
|
—
|
|
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline.
Week 24
|
72.9 score on a scale
Standard Deviation 21.21
|
70.2 score on a scale
Standard Deviation 17.31
|
—
|
|
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline.
Week 24 (Change from Baseline)
|
33.4 score on a scale
Standard Deviation 17.71
|
32.7 score on a scale
Standard Deviation 21.07
|
—
|
|
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline.
Week 36
|
70.2 score on a scale
Standard Deviation 25.61
|
78.8 score on a scale
Standard Deviation 15.50
|
—
|
|
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline.
Week 36 (Change from Baseline)
|
30.6 score on a scale
Standard Deviation 22.05
|
41.1 score on a scale
Standard Deviation 18.25
|
—
|
|
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline.
Week 52
|
75.7 score on a scale
Standard Deviation 25.61
|
80.4 score on a scale
Standard Deviation 20.26
|
—
|
|
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline.
Week 52 (Change from Baseline)
|
30.6 score on a scale
Standard Deviation 22.05
|
45.3 score on a scale
Standard Deviation 21.20
|
—
|
|
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline.
Week 104/ET
|
77.2 score on a scale
Standard Deviation 20.63
|
80.0 score on a scale
Standard Deviation 21.66
|
—
|
|
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline.
Week 104/ET (Change from Baseline)
|
36.8 score on a scale
Standard Deviation 21.84
|
45.8 score on a scale
Standard Deviation 20.46
|
—
|
SECONDARY outcome
Timeframe: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ETPopulation: Not all participants completed the IKDC score questionnaires.
Knee examination with respect to generalized laxity (tight, normal, lax) were summarized as number and percent of subjects in treatment group for Baseline and post-operative follow-up visits. The IKDC Knee Evaluation Form was comprised of 3 domains: 1) symptoms including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury. There were 18 questions and the raw score was transformed to a 0 to 100 scale score as follows: IKDC score = (raw score - lowest possible score / range of scores) x100
Outcome measures
| Measure |
Part II: RF-based Debridement
n=28 Participants
Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
|
Part II: Mechanical Debridement
n=29 Participants
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
Part II: Mechanical Debridement
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
|---|---|---|---|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Baseline - Generalized Laxity · Tight
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Week 6 - Generalized Laxity · Tight
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Week 12 - Generalized Laxity · Normal
|
25 Participants
|
26 Participants
|
—
|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Week 52 - Generalized Laxity · Tight
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Week 52 - Generalized Laxity · Normal
|
20 Participants
|
20 Participants
|
—
|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Week 52 - Generalized Laxity · Lax
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Week 104/ET - Generalized Laxity · Normal
|
20 Participants
|
15 Participants
|
—
|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Week 104/ET - Generalized Laxity · Lax
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Baseline - Generalized Laxity · Normal
|
28 Participants
|
28 Participants
|
—
|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Baseline - Generalized Laxity · Lax
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Week 6 - Generalized Laxity · Normal
|
26 Participants
|
26 Participants
|
—
|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Week 6 - Generalized Laxity · Lax
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Week 12 - Generalized Laxity · Tight
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Week 12 - Generalized Laxity · Lax
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Week 24 - Generalized Laxity · Tight
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Week 24 - Generalized Laxity · Normal
|
24 Participants
|
23 Participants
|
—
|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Week 24 - Generalized Laxity · Lax
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Week 36 - Generalized Laxity · Tight
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Week 36 - Generalized Laxity · Normal
|
19 Participants
|
21 Participants
|
—
|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Week 36 - Generalized Laxity · Lax
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
IKDC Score at Week 104/ET - Generalized Laxity · Tight
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ETPopulation: Not all participants completed the IKDC score questionnaires.
Knee examination with respect to alignment (obvious varus, normal, obvious valgus) were summarized as number and percent of subjects in treatment group for Baseline and post-operative follow-up visits. The IKDC Knee Evaluation Form was comprised of 3 domains: 1) symptoms including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury. There were 18 questions and the raw score was transformed to a 0 to 100 scale score as follows: IKDC score = (raw score - lowest possible score / range of scores) x100
Outcome measures
| Measure |
Part II: RF-based Debridement
n=28 Participants
Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
|
Part II: Mechanical Debridement
n=29 Participants
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
Part II: Mechanical Debridement
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
|---|---|---|---|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Baseline - Alignment · Obvious Varus
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Baseline - Alignment · Obvious Valgus
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Week 12 - Alignment · Obvious Valgus
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Week 52 - Alignment · Obvious Valgus
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Week 36 - Alignment · Normal
|
19 Participants
|
21 Participants
|
—
|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Baseline - Alignment · Normal
|
26 Participants
|
29 Participants
|
—
|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Week 6 - Alignment · Obvious Varus
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Week 6 - Alignment · Normal
|
25 Participants
|
26 Participants
|
—
|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Week 6 - Alignment · Obvious Valgus
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Week 12 - Alignment · Obvious Varus
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Week 12 - Alignment · Normal
|
25 Participants
|
25 Participants
|
—
|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Week 24 - Alignment · Obvious Varus
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Week 24 - Alignment · Normal
|
24 Participants
|
23 Participants
|
—
|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Week 24 - Alignment · Obvious Valgus
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Week 36 - Alignment · Obvious Varus
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Week 36 - Alignment · Obvious Valgus
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Week 52 - Alignment · Obvious Varus
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Week 52 - Alignment · Normal
|
19 Participants
|
20 Participants
|
—
|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Week 104/ET - Alignment · Obvious Varus
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Week 104/ET - Alignment · Normal
|
19 Participants
|
14 Participants
|
—
|
|
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
IKDC Score at Week 104/ET - Alignment · Obvious Valgus
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ETPopulation: Not all participants completed the IKDC score questionnaires.
Knee examination with respect to patella position (obvious baja, normal, obvious alta) were summarized as number and percent of subjects in treatment group for Baseline and post-operative follow-up visits. The IKDC Knee Evaluation Form was comprised of 3 domains: 1) symptoms including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury. There were 18 questions and the raw score was transformed to a 0 to 100 scale score as follows: IKDC score = (raw score - lowest possible score / range of scores) x100
Outcome measures
| Measure |
Part II: RF-based Debridement
n=28 Participants
Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
|
Part II: Mechanical Debridement
n=29 Participants
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
Part II: Mechanical Debridement
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
|---|---|---|---|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Week 36 - Patella Position · Obvious Baja
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Week 104/ET - Patella Position · Obvious Alta
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Baseline - Patella Position · Obvious Baja
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Baseline - Patella Position · Normal
|
28 Participants
|
29 Participants
|
—
|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Baseline - Patella Position · Obvious Alta
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Week 6 - Patella Position · Obvious Baja
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Week 6 - Patella Position · Normal
|
26 Participants
|
26 Participants
|
—
|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Week 6 - Patella Position · Obvious Alta
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Week 12 - Patella Position · Obvious Baja
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Week 12 - Patella Position · Normal
|
25 Participants
|
26 Participants
|
—
|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Week 12 - Patella Position · Obvious Alta
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Week 24 - Patella Position · Obvious Baja
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Week 24 - Patella Position · Normal
|
24 Participants
|
23 Participants
|
—
|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Week 24 - Patella Position · Obvious Alta
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Week 36 - Patella Position · Normal
|
19 Participants
|
22 Participants
|
—
|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Week 36 - Patella Position · Obvious Alta
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Week 52 - Patella Position · Obvious Baja
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Week 52 - Patella Position · Normal
|
20 Participants
|
20 Participants
|
—
|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Week 52 - Patella Position · Obvious Alta
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Week 104/ET - Patella Position · Obvious Baja
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
IKDC Scores at Week 104/ET - Patella Position · Normal
|
20 Participants
|
15 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ETPopulation: Not all participants completed the IKDC score questionnaires.
Knee examination with respect to patella subluxation/ dislocation (centered, subluxable, subluxed and dislocated) were summarized as number and percent of subjects in treatment group for Baseline and post-operative follow-up visits. The IKDC Knee Evaluation Form was comprised of 3 domains: 1) symptoms including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury. There were 18 questions and the raw score was transformed to a 0 to 100 scale score as follows: IKDC score = (raw score - lowest possible score / range of scores) x100
Outcome measures
| Measure |
Part II: RF-based Debridement
n=28 Participants
Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
|
Part II: Mechanical Debridement
n=29 Participants
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
Part II: Mechanical Debridement
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
|---|---|---|---|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 6 - Subluxation/Dislocation · Subluxed
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 24 - Subluxation/Dislocation · Subluxable
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 24 - Subluxation/Dislocation · Subluxed
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 36 - Subluxation/Dislocation · Subluxed
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 52 - Subluxation/Dislocation · Centered
|
20 Participants
|
20 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 52 - Subluxation/Dislocation · Subluxable
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 104/ET - Sublux/Dislocation · Centered
|
20 Participants
|
15 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 24 - Subluxation/Dislocation · Dislocated
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Baseline - Subluxation/Dislocation · Centered
|
28 Participants
|
29 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Baseline - Subluxation/Dislocation · Subluxable
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Baseline - Subluxation/Dislocation · Subluxed
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Baseline - Subluxation/Dislocation · Dislocated
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 6 - Subluxation/Dislocation · Centered
|
26 Participants
|
25 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 6 - Subluxation/Dislocation · Subluxable
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 6 - Subluxation/Dislocation · Dislocated
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 12 - Subluxation/Dislocation · Centered
|
25 Participants
|
26 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 12 - Subluxation/Dislocation · Subluxable
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 12 - Subluxation/Dislocation · Subluxed
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 12 - Subluxation/Dislocation · Dislocated
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 24 - Subluxation/Dislocation · Centered
|
24 Participants
|
23 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 36 - Subluxation/Dislocation · Centered
|
19 Participants
|
21 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 36 - Subluxation/Dislocation · Subluxable
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 36 - Subluxation/Dislocation · Dislocated
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 52 - Subluxation/Dislocation · Subluxed
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 52 - Subluxation/Dislocation · Dislocated
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 104/ET - Sublux/Dislocation · Subluxable
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 104/ET - Sublux/Dislocation · Subluxed
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
IKDC Scores at Week 104/ET - Sublux/Dislocation · Dislocated
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ETPopulation: Not all participants completed the KOOS questionnaires.
The scores of 5 subscales of Knee Injury and Osteoarthritis Outcome Score (KOOS) (i.e., pain, other symptoms, function in daily living \[ADL\], function in sport and recreation \[Sport/Rec\], and knee-related Quality of Life \[QoL\]) change from Baseline were summarized descriptively by treatment group. An ANCOVA model was used to compare the differences in the devices for change from Baseline in the KOOS subscale score at each of the scheduled post-operative visits. Each subscale response was based on a 5-point Likert system with each response score ranging from 0 (no problems) to 4 (extreme problems). A score of 100 indicated no problems and a score of 0 indicated extreme problems. The KOOS calculations were calculated as follows: Individual KOOS subscale scores = 100 - (mean of the observed items within the subscale x100) / 4 Change from Baseline in KOOS at Week (x) or Day (x) = KOOS at Week (x) or Day (x) - KOOS at Baseline
Outcome measures
| Measure |
Part II: RF-based Debridement
n=28 Participants
Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
|
Part II: Mechanical Debridement
n=29 Participants
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
Part II: Mechanical Debridement
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
|---|---|---|---|
|
Change in KOOS Scores From Baseline
Pain - Week 6
|
70.9 score on a scale
Standard Deviation 19.62
|
80.4 score on a scale
Standard Deviation 14.90
|
—
|
|
Change in KOOS Scores From Baseline
Other Symptoms - Week 6
|
73.5 score on a scale
Standard Deviation 17.64
|
75.7 score on a scale
Standard Deviation 18.48
|
—
|
|
Change in KOOS Scores From Baseline
Other Symptoms - Week 6 (Change from Baseline)
|
16.0 score on a scale
Standard Deviation 20.76
|
20.6 score on a scale
Standard Deviation 22.70
|
—
|
|
Change in KOOS Scores From Baseline
Other Symptoms - Week 12
|
81.3 score on a scale
Standard Deviation 19.73
|
83.1 score on a scale
Standard Deviation 15.14
|
—
|
|
Change in KOOS Scores From Baseline
Other Symptoms - Week 12 (Change from Baseline)
|
25.0 score on a scale
Standard Deviation 25.63
|
28.3 score on a scale
Standard Deviation 20.92
|
—
|
|
Change in KOOS Scores From Baseline
Other Symptoms - Week 36 (Change from Baseline)
|
17.0 score on a scale
Standard Deviation 24.90
|
31.7 score on a scale
Standard Deviation 17.26
|
—
|
|
Change in KOOS Scores From Baseline
Other Symptoms - Week 52 (Change from Baseline)
|
19.8 score on a scale
Standard Deviation 26.33
|
34.6 score on a scale
Standard Deviation 19.15
|
—
|
|
Change in KOOS Scores From Baseline
ADLs - Week 12
|
84.1 score on a scale
Standard Deviation 21.02
|
85.3 score on a scale
Standard Deviation 14.36
|
—
|
|
Change in KOOS Scores From Baseline
ADLs - Week 24
|
84.6 score on a scale
Standard Deviation 20.88
|
87.9 score on a scale
Standard Deviation 12.05
|
—
|
|
Change in KOOS Scores From Baseline
ADLs - Week 52 (Change from Baseline)
|
30.4 score on a scale
Standard Deviation 24.06
|
32.3 score on a scale
Standard Deviation 18.07
|
—
|
|
Change in KOOS Scores From Baseline
ADLs - Week 104/ET
|
89.0 score on a scale
Standard Deviation 16.72
|
90.8 score on a scale
Standard Deviation 13.39
|
—
|
|
Change in KOOS Scores From Baseline
Sport/Rec - Week 6 (Change from Baseline)
|
23.1 score on a scale
Standard Deviation 27.00
|
29.4 score on a scale
Standard Deviation 35.06
|
—
|
|
Change in KOOS Scores From Baseline
Sport/Rec - Week 12 (Change from Baseline)
|
42.3 score on a scale
Standard Deviation 30.24
|
38.2 score on a scale
Standard Deviation 28.53
|
—
|
|
Change in KOOS Scores From Baseline
Other Symptoms - Week 24
|
79.8 score on a scale
Standard Deviation 20.22
|
80.4 score on a scale
Standard Deviation 13.99
|
—
|
|
Change in KOOS Scores From Baseline
Other Symptoms - Week 24 (Change from Baseline)
|
21.9 score on a scale
Standard Deviation 22.55
|
25.2 score on a scale
Standard Deviation 18.67
|
—
|
|
Change in KOOS Scores From Baseline
Other Symptoms - Week 36
|
74.1 score on a scale
Standard Deviation 23.17
|
87.7 score on a scale
Standard Deviation 10.61
|
—
|
|
Change in KOOS Scores From Baseline
Other Symptoms - Week 52
|
78.7 score on a scale
Standard Deviation 24.12
|
88.0 score on a scale
Standard Deviation 14.53
|
—
|
|
Change in KOOS Scores From Baseline
Other Symptoms - Week 104/ET
|
83.9 score on a scale
Standard Deviation 17.71
|
85.7 score on a scale
Standard Deviation 15.57
|
—
|
|
Change in KOOS Scores From Baseline
Other Symptoms -Week 104/ET (Change from Baseline)
|
24.5 score on a scale
Standard Deviation 23.53
|
34.8 score on a scale
Standard Deviation 17.78
|
—
|
|
Change in KOOS Scores From Baseline
ADLs - Baseline
|
53.5 score on a scale
Standard Deviation 21.48
|
57.3 score on a scale
Standard Deviation 15.31
|
—
|
|
Change in KOOS Scores From Baseline
ADLs - Week 6
|
76.6 score on a scale
Standard Deviation 21.09
|
86.2 score on a scale
Standard Deviation 12.18
|
—
|
|
Change in KOOS Scores From Baseline
ADLs - Week 6 (Change from Baseline)
|
23.3 score on a scale
Standard Deviation 18.43
|
29.6 score on a scale
Standard Deviation 16.26
|
—
|
|
Change in KOOS Scores From Baseline
ADLs - Week 12 (Change from Baseline)
|
32.0 score on a scale
Standard Deviation 24.33
|
27.0 score on a scale
Standard Deviation 16.16
|
—
|
|
Change in KOOS Scores From Baseline
ADLs - Week 24 (Change from Baseline)
|
31.1 score on a scale
Standard Deviation 24.53
|
31.0 score on a scale
Standard Deviation 16.94
|
—
|
|
Change in KOOS Scores From Baseline
ADLs - Week 36
|
78.7 score on a scale
Standard Deviation 23.58
|
91.3 score on a scale
Standard Deviation 11.06
|
—
|
|
Change in KOOS Scores From Baseline
ADLs - Week 36 (Change from Baseline)
|
24.3 score on a scale
Standard Deviation 24.32
|
32.0 score on a scale
Standard Deviation 14.51
|
—
|
|
Change in KOOS Scores From Baseline
ADLs - Week 52
|
83.6 score on a scale
Standard Deviation 23.85
|
89.2 score on a scale
Standard Deviation 17.98
|
—
|
|
Change in KOOS Scores From Baseline
ADLs - Week 104/ET (Change from Baseline)
|
32.6 score on a scale
Standard Deviation 24.53
|
36.3 score on a scale
Standard Deviation 16.67
|
—
|
|
Change in KOOS Scores From Baseline
Sport/Rec - Baseline
|
29.9 score on a scale
Standard Deviation 22.68
|
30.2 score on a scale
Standard Deviation 23.58
|
—
|
|
Change in KOOS Scores From Baseline
Sport/Rec - Week 6
|
54.1 score on a scale
Standard Deviation 25.87
|
61.5 score on a scale
Standard Deviation 24.25
|
—
|
|
Change in KOOS Scores From Baseline
Sport/Rec - Week 12
|
72.0 score on a scale
Standard Deviation 24.66
|
67.0 score on a scale
Standard Deviation 25.96
|
—
|
|
Change in KOOS Scores From Baseline
Sport/Rec - Week 24
|
65.6 score on a scale
Standard Deviation 30.59
|
69.3 score on a scale
Standard Deviation 22.88
|
—
|
|
Change in KOOS Scores From Baseline
Sport/Rec - Week 24 (Change from Baseline)
|
34.9 score on a scale
Standard Deviation 32.46
|
40.4 score on a scale
Standard Deviation 32.68
|
—
|
|
Change in KOOS Scores From Baseline
Sport/Rec - Week 36
|
63.0 score on a scale
Standard Deviation 33.02
|
75.9 score on a scale
Standard Deviation 24.33
|
—
|
|
Change in KOOS Scores From Baseline
Sport/Rec - Week 36 (Change from Baseline)
|
32.8 score on a scale
Standard Deviation 35.60
|
45.2 score on a scale
Standard Deviation 29.38
|
—
|
|
Change in KOOS Scores From Baseline
Sport/Rec - Week 52
|
73.0 score on a scale
Standard Deviation 30.28
|
78.3 score on a scale
Standard Deviation 25.09
|
—
|
|
Change in KOOS Scores From Baseline
Sport/Rec - Week 52 (Change from Baseline)
|
41.4 score on a scale
Standard Deviation 30.56
|
51.5 score on a scale
Standard Deviation 26.81
|
—
|
|
Change in KOOS Scores From Baseline
Sport/Rec - Week 104/ET
|
76.0 score on a scale
Standard Deviation 26.49
|
77.8 score on a scale
Standard Deviation 27.88
|
—
|
|
Change in KOOS Scores From Baseline
Sport/Rec - Week 104/ET (Change from Baseline)
|
44.2 score on a scale
Standard Deviation 25.90
|
53.8 score on a scale
Standard Deviation 29.38
|
—
|
|
Change in KOOS Scores From Baseline
QoL - Baseline
|
28.8 score on a scale
Standard Deviation 16.78
|
28.4 score on a scale
Standard Deviation 14.90
|
—
|
|
Change in KOOS Scores From Baseline
QoL - Week 6
|
59.7 score on a scale
Standard Deviation 21.11
|
59.7 score on a scale
Standard Deviation 19.79
|
—
|
|
Change in KOOS Scores From Baseline
QoL - Week 6 (Change from Baseline)
|
31.0 score on a scale
Standard Deviation 25.09
|
31.3 score on a scale
Standard Deviation 26.69
|
—
|
|
Change in KOOS Scores From Baseline
QoL - Week 12
|
66.5 score on a scale
Standard Deviation 24.13
|
66.6 score on a scale
Standard Deviation 25.55
|
—
|
|
Change in KOOS Scores From Baseline
QoL - Week 12 (Change from Baseline)
|
39.0 score on a scale
Standard Deviation 27.56
|
37.7 score on a scale
Standard Deviation 31.00
|
—
|
|
Change in KOOS Scores From Baseline
QoL - Week 24
|
67.2 score on a scale
Standard Deviation 26.98
|
70.7 score on a scale
Standard Deviation 21.02
|
—
|
|
Change in KOOS Scores From Baseline
QoL - Week 24 (Change from Baseline)
|
36.2 score on a scale
Standard Deviation 34.4
|
41.0 score on a scale
Standard Deviation 24.70
|
—
|
|
Change in KOOS Scores From Baseline
QoL - Week 36
|
66.3 score on a scale
Standard Deviation 32.66
|
77.3 score on a scale
Standard Deviation 23.82
|
—
|
|
Change in KOOS Scores From Baseline
QoL - Week 36 (Change from Baseline)
|
35.9 score on a scale
Standard Deviation 31.86
|
47.4 score on a scale
Standard Deviation 25.34
|
—
|
|
Change in KOOS Scores From Baseline
QoL - Week 52
|
72.5 score on a scale
Standard Deviation 28.42
|
75.6 score on a scale
Standard Deviation 26.59
|
—
|
|
Change in KOOS Scores From Baseline
QoL - Week 52 (Change from Baseline)
|
41.9 score on a scale
Standard Deviation 25.50
|
47.5 score on a scale
Standard Deviation 27.01
|
—
|
|
Change in KOOS Scores From Baseline
QoL - Week 104/ET
|
79.1 score on a scale
Standard Deviation 21.77
|
76.7 score on a scale
Standard Deviation 25.38
|
—
|
|
Change in KOOS Scores From Baseline
QoL - Week 104/ET (Change from Baseline)
|
46.9 score on a scale
Standard Deviation 25.29
|
50.8 score on a scale
Standard Deviation 22.89
|
—
|
|
Change in KOOS Scores From Baseline
Average KOOS Score - Baseline
|
43.4 score on a scale
Standard Deviation 17.82
|
44.2 score on a scale
Standard Deviation 13.56
|
—
|
|
Change in KOOS Scores From Baseline
Average KOOS Score - Week 6
|
67.0 score on a scale
Standard Deviation 19.77
|
72.7 score on a scale
Standard Deviation 14.47
|
—
|
|
Change in KOOS Scores From Baseline
Average KOOS Score - Week 6 (Change from Baseline)
|
23.7 score on a scale
Standard Deviation 18.85
|
28.2 score on a scale
Standard Deviation 20.86
|
—
|
|
Change in KOOS Scores From Baseline
Average KOOS Score - Week 12
|
76.9 score on a scale
Standard Deviation 20.81
|
76.9 score on a scale
Standard Deviation 18.59
|
—
|
|
Change in KOOS Scores From Baseline
Average KOOS Score - Week 12 (Change/Baseline)
|
34.8 score on a scale
Standard Deviation 23.84
|
32.3 score on a scale
Standard Deviation 21.05
|
—
|
|
Change in KOOS Scores From Baseline
Average KOOS Score - Week 24
|
75.1 score on a scale
Standard Deviation 22.69
|
77.8 score on a scale
Standard Deviation 15.70
|
—
|
|
Change in KOOS Scores From Baseline
Average KOOS Score - Week 24 (Change/Baseline)
|
31.3 score on a scale
Standard Deviation 23.01
|
33.3 score on a scale
Standard Deviation 20.17
|
—
|
|
Change in KOOS Scores From Baseline
Average KOOS Score - Week 36
|
71.6 score on a scale
Standard Deviation 26.41
|
84.2 score on a scale
Standard Deviation 14.59
|
—
|
|
Change in KOOS Scores From Baseline
Average KOOS Score - Week 36 (Change/Baseline)
|
27.9 score on a scale
Standard Deviation 25.78
|
38.6 score on a scale
Standard Deviation 16.82
|
—
|
|
Change in KOOS Scores From Baseline
Average KOOS Score - Week 52
|
77.9 score on a scale
Standard Deviation 25.41
|
83.7 score on a scale
Standard Deviation 19.66
|
—
|
|
Change in KOOS Scores From Baseline
Average KOOS Score - Week 52 (Change/Baseline)
|
33.9 score on a scale
Standard Deviation 23.42
|
40.8 score on a scale
Standard Deviation 19.97
|
—
|
|
Change in KOOS Scores From Baseline
Average KOOS Score - Week 104/ET
|
83.3 score on a scale
Standard Deviation 17.88
|
83.9 score on a scale
Standard Deviation 19.16
|
—
|
|
Change in KOOS Scores From Baseline
Average KOOS Score - Week 104/ET (Change/Baseline)
|
37.4 score on a scale
Standard Deviation 21.47
|
43.0 score on a scale
Standard Deviation 18.22
|
—
|
|
Change in KOOS Scores From Baseline
Pain - Baseline
|
46.2 score on a scale
Standard Deviation 17.26
|
50.6 score on a scale
Standard Deviation 13.10
|
—
|
|
Change in KOOS Scores From Baseline
Pain - Week 6 (Change from Baseline)
|
25.3 score on a scale
Standard Deviation 16.92
|
29.9 score on a scale
Standard Deviation 19.66
|
—
|
|
Change in KOOS Scores From Baseline
Pain - Week 12
|
80.6 score on a scale
Standard Deviation 20.05
|
82.3 score on a scale
Standard Deviation 17.23
|
—
|
|
Change in KOOS Scores From Baseline
Pain - Week 12 (Change from Baseline)
|
35.8 score on a scale
Standard Deviation 21.92
|
30.3 score on a scale
Standard Deviation 19.83
|
—
|
|
Change in KOOS Scores From Baseline
Pain - Week 24
|
78.5 score on a scale
Standard Deviation 22.15
|
80.4 score on a scale
Standard Deviation 15.39
|
—
|
|
Change in KOOS Scores From Baseline
Pain - Week 24 (Change from Baseline)
|
32.5 score on a scale
Standard Deviation 21.91
|
29.1 score on a scale
Standard Deviation 18.37
|
—
|
|
Change in KOOS Scores From Baseline
Pain - Week 36
|
78.7 score on a scale
Standard Deviation 25.98
|
89.0 score on a scale
Standard Deviation 9.55
|
—
|
|
Change in KOOS Scores From Baseline
Pain - Week 36 (Change from Baseline)
|
29.6 score on a scale
Standard Deviation 25.92
|
36.8 score on a scale
Standard Deviation 12.94
|
—
|
|
Change in KOOS Scores From Baseline
Pain - Week 52
|
81.5 score on a scale
Standard Deviation 24.91
|
87.6 score on a scale
Standard Deviation 18.30
|
—
|
|
Change in KOOS Scores From Baseline
Pain - Week 52 (Change from Baseline)
|
35.8 score on a scale
Standard Deviation 21.98
|
38.2 score on a scale
Standard Deviation 18.79
|
—
|
|
Change in KOOS Scores From Baseline
Pain - Week 104/ET
|
88.3 score on a scale
Standard Deviation 15.18
|
88.5 score on a scale
Standard Deviation 17.47
|
—
|
|
Change in KOOS Scores From Baseline
Pain - Week 104/ET (Change from Baseline)
|
38.9 score on a scale
Standard Deviation 21.50
|
39.3 score on a scale
Standard Deviation 15.17
|
—
|
|
Change in KOOS Scores From Baseline
Other Symptoms - Baseline
|
58.4 score on a scale
Standard Deviation 20.72
|
54.7 score on a scale
Standard Deviation 16.70
|
—
|
SECONDARY outcome
Timeframe: Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ETPopulation: Not all participants completed the VAS pain score questionnaire.
The VAS knee pain scores were assessed at Baseline, post-operative visits (Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET) and change from Baseline were summarized descriptively by treatment group. An ANCOVA model was used to compare the differences in the devices for change from Baseline in the VAS knee pain score at each of the scheduled post-operative visits. The model had change in VAS knee pain as the response variable and treatment, Baseline VAS knee pain, site, treatment-by-site interaction, lesion-grade, and lesion-grade interaction as independent variables. Scores ranged from 0 to 100 with pain intensity measured as none, mild, moderate, or severe: No pain (0-4) Mild pain (5-44) Moderate pain (45-74) Severe pain (75-100) VAS scores were calculated as: Change in VAS knee pain score from Baseline at Week (x) or Day (x) = VAS knee pain at Week (x) or Day (x) - VAS knee pain at Baseline
Outcome measures
| Measure |
Part II: RF-based Debridement
n=28 Participants
Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
|
Part II: Mechanical Debridement
n=29 Participants
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
Part II: Mechanical Debridement
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
|---|---|---|---|
|
Change in Visual Analog Scale (VAS) Scores From Baseline
Day 10
|
28.7 units on a scale
Standard Deviation 23.62
|
17.6 units on a scale
Standard Deviation 18.69
|
—
|
|
Change in Visual Analog Scale (VAS) Scores From Baseline
Day 10 (Change from Baseline)
|
-29.0 units on a scale
Standard Deviation 21.29
|
-42.2 units on a scale
Standard Deviation 23.77
|
—
|
|
Change in Visual Analog Scale (VAS) Scores From Baseline
Week 6
|
17.8 units on a scale
Standard Deviation 23.05
|
13.8 units on a scale
Standard Deviation 18.71
|
—
|
|
Change in Visual Analog Scale (VAS) Scores From Baseline
Week 6 (Change from Baseline)
|
-38.1 units on a scale
Standard Deviation 22.75
|
-44.5 units on a scale
Standard Deviation 19.90
|
—
|
|
Change in Visual Analog Scale (VAS) Scores From Baseline
Week 12
|
12.6 units on a scale
Standard Deviation 17.71
|
15.2 units on a scale
Standard Deviation 17.79
|
—
|
|
Change in Visual Analog Scale (VAS) Scores From Baseline
Week 12 (Change from Baseline)
|
-45.8 units on a scale
Standard Deviation 23.98
|
-41.3 units on a scale
Standard Deviation 21.18
|
—
|
|
Change in Visual Analog Scale (VAS) Scores From Baseline
Week 24
|
15.3 units on a scale
Standard Deviation 23.88
|
13.9 units on a scale
Standard Deviation 15.38
|
—
|
|
Change in Visual Analog Scale (VAS) Scores From Baseline
Week 24 (Change from Baseline)
|
-42.6 units on a scale
Standard Deviation 21.98
|
-44.2 units on a scale
Standard Deviation 18.64
|
—
|
|
Change in Visual Analog Scale (VAS) Scores From Baseline
Week 36
|
19.1 units on a scale
Standard Deviation 26.63
|
7.9 units on a scale
Standard Deviation 13.53
|
—
|
|
Change in Visual Analog Scale (VAS) Scores From Baseline
Week 36 (Change from Baseline)
|
-37.5 units on a scale
Standard Deviation 28.20
|
-49.6 units on a scale
Standard Deviation 17.18
|
—
|
|
Change in Visual Analog Scale (VAS) Scores From Baseline
Week 52
|
11.5 units on a scale
Standard Deviation 20.08
|
9.3 units on a scale
Standard Deviation 19.97
|
—
|
|
Change in Visual Analog Scale (VAS) Scores From Baseline
Week 52 (Change from Baseline)
|
-45.8 units on a scale
Standard Deviation 20.74
|
-49.5 units on a scale
Standard Deviation 24.54
|
—
|
|
Change in Visual Analog Scale (VAS) Scores From Baseline
Week 104/ET
|
8.4 units on a scale
Standard Deviation 14.22
|
9.9 units on a scale
Standard Deviation 20.60
|
—
|
|
Change in Visual Analog Scale (VAS) Scores From Baseline
Week 104/ET (Change from Baseline)
|
-47.9 units on a scale
Standard Deviation 25.92
|
-50.7 units on a scale
Standard Deviation 30.82
|
—
|
|
Change in Visual Analog Scale (VAS) Scores From Baseline
Baseline
|
57.6 units on a scale
Standard Deviation 19.68
|
59.8 units on a scale
Standard Deviation 16.15
|
—
|
SECONDARY outcome
Timeframe: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ETPopulation: Not all participants completed the SF-12 questionnaire.
SF-12 PCS scores at Baseline, post-operative visits (Weeks 6, 12, 24, 36, 52 and 104) and changes from Baseline were summarized descriptively by treatment group. The SF-12 health survey categories included: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. An ANCOVA model was used to compare the difference in the devices for change from Baseline in the SF-12 PCS scores at each of the scheduled post-operative visits. The model had change in SF-12 PCS score as the response variable and treatment, Baseline SF-12 PCS score, site, treatment-by-site interaction, lesion-grade and treatment-by-lesion grade interaction as independent variables. Results were expressed as the PCS. Scores could range from 0 (the worst) to 100 (the best). SF-12 scores for PCS were calculated as: Change in SF-12 PCS score from Baseline at Week (x) = PCS score at Week (x) - PCS score at Baseline
Outcome measures
| Measure |
Part II: RF-based Debridement
n=28 Participants
Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
|
Part II: Mechanical Debridement
n=29 Participants
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
Part II: Mechanical Debridement
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
|---|---|---|---|
|
Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score
Baseline PCS
|
36.5 score on a scale
Standard Deviation 10.65
|
38.6 score on a scale
Standard Deviation 9.63
|
—
|
|
Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score
Week 6 PCS
|
45.1 score on a scale
Standard Deviation 9.14
|
46.6 score on a scale
Standard Deviation 8.27
|
—
|
|
Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score
Week 6 PCS (Change from Baseline)
|
8.2 score on a scale
Standard Deviation 12.62
|
6.7 score on a scale
Standard Deviation 9.31
|
—
|
|
Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score
Week 12 PCS
|
50.0 score on a scale
Standard Deviation 7.87
|
46.6 score on a scale
Standard Deviation 8.27
|
—
|
|
Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score
Week 12 PCS (Change from Baseline)
|
13.4 score on a scale
Standard Deviation 13.14
|
9.4 score on a scale
Standard Deviation 10.49
|
—
|
|
Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score
Week 24 PCS
|
48.5 score on a scale
Standard Deviation 9.60
|
50.2 score on a scale
Standard Deviation 8.19
|
—
|
|
Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score
Week 24 PCS (Change from Baseline)
|
11.1 score on a scale
Standard Deviation 13.14
|
11.6 score on a scale
Standard Deviation 11.12
|
—
|
|
Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score
Week 36 PCS
|
46.8 score on a scale
Standard Deviation 11.49
|
52.5 score on a scale
Standard Deviation 6.98
|
—
|
|
Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score
Week 36 PCS (Change from Baseline)
|
9.3 score on a scale
Standard Deviation 13.81
|
13.1 score on a scale
Standard Deviation 10.43
|
—
|
|
Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score
Week 52 PCS
|
48.9 score on a scale
Standard Deviation 10.24
|
52.5 score on a scale
Standard Deviation 8.72
|
—
|
|
Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score
Week 52 PCS (Change from Baseline)
|
11.6 score on a scale
Standard Deviation 10.99
|
14.6 score on a scale
Standard Deviation 11.55
|
—
|
|
Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score
Week 104/ET PCS
|
51.9 score on a scale
Standard Deviation 6.96
|
51.6 score on a scale
Standard Deviation 8.35
|
—
|
|
Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score
Week 104/ET PCS (Change from Baseline)
|
14.1 score on a scale
Standard Deviation 11.02
|
15.3 score on a scale
Standard Deviation 11.42
|
—
|
SECONDARY outcome
Timeframe: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ETPopulation: Not all participants completed the SF-12 questionnaire.
SF-12 MCS scores at Baseline, post-operative visits (Weeks 6, 12, 24, 36, 52, and 104) and changes from Baseline were summarized descriptively by treatment group. The SF-12 health survey categories included: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. An ANCOVA model was used to compare the difference in the devices for change from Baseline in the SF-12 MCS scores at each of the scheduled post-operative visits. The model had change in SF-12 MCS score as the response variable and treatment, Baseline SF-12 MCS score, site, treatment-by-site interaction, lesion-grade and treatment-by-lesion grade interaction as independent variables. Results were expressed as the MCS. Scores could range from 0 (the worst) to 100 (the best). SF-12 scores for MCS were calculated as: Change in SF-12 MCS score from Baseline at Week (x) = MCS score at Week (x) - MCS score at Baseline
Outcome measures
| Measure |
Part II: RF-based Debridement
n=28 Participants
Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
|
Part II: Mechanical Debridement
n=29 Participants
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
Part II: Mechanical Debridement
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
|---|---|---|---|
|
Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score
Baseline MCS
|
55.9 score on a scale
Standard Deviation 9.98
|
55.1 score on a scale
Standard Deviation 9.52
|
—
|
|
Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score
Week 6 MCS
|
55.1 score on a scale
Standard Deviation 8.44
|
57.5 score on a scale
Standard Deviation 9.63
|
—
|
|
Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score
Week 6 MCS (Change from Baseline)
|
-0.1 score on a scale
Standard Deviation 8.87
|
3.4 score on a scale
Standard Deviation 8.27
|
—
|
|
Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score
Week 12 MCS
|
55.6 score on a scale
Standard Deviation 7.47
|
55.9 score on a scale
Standard Deviation 7.75
|
—
|
|
Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score
Week 12 MCS (Change from Baseline)
|
0.5 score on a scale
Standard Deviation 10.97
|
1.2 score on a scale
Standard Deviation 8.05
|
—
|
|
Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score
Week 24 MCS
|
56.6 score on a scale
Standard Deviation 5.32
|
56.9 score on a scale
Standard Deviation 8.47
|
—
|
|
Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score
Week 24 MCS (Change from Baseline)
|
0.7 score on a scale
Standard Deviation 10.17
|
2.6 score on a scale
Standard Deviation 8.32
|
—
|
|
Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score
Week 36 MCS
|
55.5 score on a scale
Standard Deviation 6.49
|
57.1 score on a scale
Standard Deviation 4.81
|
—
|
|
Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score
Week 36 MCS (Change from Baseline)
|
0.1 score on a scale
Standard Deviation 10.63
|
1.8 score on a scale
Standard Deviation 7.61
|
—
|
|
Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score
Week 52 MCS
|
56.1 score on a scale
Standard Deviation 7.19
|
56.1 score on a scale
Standard Deviation 4.90
|
—
|
|
Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score
Week 52 MCS (Change from Baseline)
|
0.6 score on a scale
Standard Deviation 9.46
|
1.5 score on a scale
Standard Deviation 10.35
|
—
|
|
Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score
Week 104/ET MCS
|
56.1 score on a scale
Standard Deviation 5.17
|
55.7 score on a scale
Standard Deviation 9.91
|
—
|
|
Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score
Week 104/ET MCS (Change from Baseline)
|
-0.4 score on a scale
Standard Deviation 10.84
|
0.1 score on a scale
Standard Deviation 10.54
|
—
|
SECONDARY outcome
Timeframe: Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ETPopulation: Not all participants completed the EQ-5D-5L questionnaire.
The EQ-5D-5L and EQ-VAS surveys were assessed at the specified time points. The EQ-5D-5L score was composed of 5 dimensions to assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on participant's responses. Each individual category calculated a score of between -1 and +1. A score of -1 showed the worst improvement and a score of +1 showed the most improvement. Summary total scores for EQ-5D-5L were calculated as: Change in EQ-5D-5L score from Baseline at Week (x) or Day (x) = EQ-5D-5L score at Week (x) or Day (x) - EQ-5D-5L score at Baseline
Outcome measures
| Measure |
Part II: RF-based Debridement
n=28 Participants
Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
|
Part II: Mechanical Debridement
n=29 Participants
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
Part II: Mechanical Debridement
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
|---|---|---|---|
|
Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score)
Day 10 (Change from Baseline)
|
0.024 units on a scale
Standard Deviation 0.1331
|
0.043 units on a scale
Standard Deviation 0.1151
|
—
|
|
Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score)
Week 6
|
0.791 units on a scale
Standard Deviation 0.1528
|
0.825 units on a scale
Standard Deviation 0.0999
|
—
|
|
Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score)
Week 52 (Change from Baseline)
|
0.135 units on a scale
Standard Deviation 0.1502
|
0.162 units on a scale
Standard Deviation 0.1362
|
—
|
|
Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score)
Week 24 (Change from Baseline)
|
0.100 units on a scale
Standard Deviation 0.1436
|
0.105 units on a scale
Standard Deviation 0.1269
|
—
|
|
Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score)
Week 36
|
0.806 units on a scale
Standard Deviation 0.1650
|
0.914 units on a scale
Standard Deviation 0.0895
|
—
|
|
Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score)
Week 36 (Change from Baseline)
|
0.096 units on a scale
Standard Deviation 0.1524
|
0.143 units on a scale
Standard Deviation 0.0743
|
—
|
|
Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score)
Week 52
|
0.835 units on a scale
Standard Deviation 0.1950
|
0.911 units on a scale
Standard Deviation 0.1267
|
—
|
|
Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score)
Week 104/ET
|
0.843 units on a scale
Standard Deviation 0.1290
|
0.906 units on a scale
Standard Deviation 0.1298
|
—
|
|
Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score)
Week 104/ET (Change from Baseline)
|
0.106 units on a scale
Standard Deviation 0.1381
|
0.167 units on a scale
Standard Deviation 0.1470
|
—
|
|
Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score)
EQ-5D-5L Summary Total Score (Baseline)
|
0.714 units on a scale
Standard Deviation 0.1503
|
0.745 units on a scale
Standard Deviation 0.910
|
—
|
|
Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score)
Day 10
|
0.738 units on a scale
Standard Deviation 0.1309
|
0.788 units on a scale
Standard Deviation 0.0967
|
—
|
|
Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score)
Week 6 (Change from Baseline)
|
0.083 units on a scale
Standard Deviation 0.1080
|
0.081 units on a scale
Standard Deviation 0.1318
|
—
|
|
Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score)
Week 12
|
0.823 units on a scale
Standard Deviation 0.1614
|
0.854 units on a scale
Standard Deviation 0.1145
|
—
|
|
Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score)
Week 12 (Change from Baseline)
|
0.116 units on a scale
Standard Deviation 0.1182
|
0.094 units on a scale
Standard Deviation 0.1137
|
—
|
|
Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score)
Week 24
|
0.814 units on a scale
Standard Deviation 0.1473
|
0.854 units on a scale
Standard Deviation 0.1047
|
—
|
SECONDARY outcome
Timeframe: Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ETPopulation: Not all participants completed the EQ-VAS questionnaire.
The EQ-5D-5L and EQ-VAS surveys were assessed at the specified time points. The EQ-5D-5L score was composed of 5 dimensions to assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on participant's responses. The EQ-VAS score ranged from 0 to 100 with higher scores representing better health and lower scores representing worse health. Summary total scores for EQ-VAS were calculated as: Change in EQ-VAS score from Baseline at Week (x) or Day (x) = EQ-VAS score at Week (x) or Day (x) - EQ-VAS score at Baseline
Outcome measures
| Measure |
Part II: RF-based Debridement
n=28 Participants
Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
|
Part II: Mechanical Debridement
n=29 Participants
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
Part II: Mechanical Debridement
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
|---|---|---|---|
|
Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score)
EQ-VAS Summary Total Score (Baseline)
|
74.9 score on a scale
Standard Deviation 21.70
|
76.3 score on a scale
Standard Deviation 17.90
|
—
|
|
Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score)
Day 10
|
80.7 score on a scale
Standard Deviation 16.85
|
88.0 score on a scale
Standard Deviation 8.87
|
—
|
|
Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score)
Day 10 (Change from Baseline)
|
5.8 score on a scale
Standard Deviation 18.42
|
11.7 score on a scale
Standard Deviation 16.80
|
—
|
|
Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score)
Week 6
|
84.0 score on a scale
Standard Deviation 13.99
|
89.5 score on a scale
Standard Deviation 7.41
|
—
|
|
Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score)
Week 6 (Change from Baseline)
|
10.5 score on a scale
Standard Deviation 14.82
|
14.1 score on a scale
Standard Deviation 17.87
|
—
|
|
Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score)
Week 12
|
84.6 score on a scale
Standard Deviation 14.35
|
90.1 score on a scale
Standard Deviation 7.06
|
—
|
|
Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score)
Week 12 (Change from Baseline)
|
10.8 score on a scale
Standard Deviation 13.11
|
14.3 score on a scale
Standard Deviation 18.55
|
—
|
|
Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score)
Week 24
|
87.3 score on a scale
Standard Deviation 12.97
|
88.4 score on a scale
Standard Deviation 10.98
|
—
|
|
Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score)
Week 24 (Change from Baseline)
|
13.3 score on a scale
Standard Deviation 16.09
|
14.0 score on a scale
Standard Deviation 16.63
|
—
|
|
Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score)
Week 36
|
84.7 score on a scale
Standard Deviation 12.97
|
91.0 score on a scale
Standard Deviation 6.01
|
—
|
|
Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score)
Week 36 (Change from Baseline)
|
13.3 score on a scale
Standard Deviation 16.09
|
15.0 score on a scale
Standard Deviation 17.81
|
—
|
|
Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score)
Week 52
|
84.1 score on a scale
Standard Deviation 18.50
|
90.2 score on a scale
Standard Deviation 8.60
|
—
|
|
Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score)
Week 52 (Change from Baseline)
|
8.6 score on a scale
Standard Deviation 18.55
|
15.1 score on a scale
Standard Deviation 17.24
|
—
|
|
Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score)
Week 104/ET
|
87.1 score on a scale
Standard Deviation 12.96
|
90.3 score on a scale
Standard Deviation 11.55
|
—
|
|
Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score)
Week 104/ET (Change from Baseline)
|
9.2 score on a scale
Standard Deviation 13.04
|
14.9 score on a scale
Standard Deviation 13.27
|
—
|
SECONDARY outcome
Timeframe: Postop Weeks 52 and 104/ETPopulation: Not all participants completed the subject satisfaction questionnaire.
Subjects were questioned regarding their satisfaction with study treatment for knee pain.
Outcome measures
| Measure |
Part II: RF-based Debridement
n=29 Participants
Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
|
Part II: Mechanical Debridement
n=29 Participants
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
Part II: Mechanical Debridement
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
|---|---|---|---|
|
Subject Satisfaction Postoperatively at Weeks 52 and 104
Week 104/ET · Very Dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Subject Satisfaction Postoperatively at Weeks 52 and 104
Week 52 · Extremely Satisfied
|
0 Participants
|
0 Participants
|
—
|
|
Subject Satisfaction Postoperatively at Weeks 52 and 104
Week 52 · Very Satisfied
|
12 Participants
|
16 Participants
|
—
|
|
Subject Satisfaction Postoperatively at Weeks 52 and 104
Week 52 · Somewhat Satisfied
|
5 Participants
|
2 Participants
|
—
|
|
Subject Satisfaction Postoperatively at Weeks 52 and 104
Week 52 · Somewhat Dissatisfied
|
2 Participants
|
2 Participants
|
—
|
|
Subject Satisfaction Postoperatively at Weeks 52 and 104
Week 52 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Subject Satisfaction Postoperatively at Weeks 52 and 104
Week 52 · Extremely Dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Subject Satisfaction Postoperatively at Weeks 52 and 104
Week 104/ET · Extremely Satisfied
|
0 Participants
|
0 Participants
|
—
|
|
Subject Satisfaction Postoperatively at Weeks 52 and 104
Week 104/ET · Very Satisfied
|
15 Participants
|
13 Participants
|
—
|
|
Subject Satisfaction Postoperatively at Weeks 52 and 104
Week 104/ET · Somewhat Satisfied
|
5 Participants
|
2 Participants
|
—
|
|
Subject Satisfaction Postoperatively at Weeks 52 and 104
Week 104/ET · Somewhat Dissatisfied
|
0 Participants
|
0 Participants
|
—
|
|
Subject Satisfaction Postoperatively at Weeks 52 and 104
Week 104/ET · Extremely Dissatisfied
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Postop Day 10, Day 10 to Week 52, Week 52 to Week 104/ETPopulation: Only Baseline subjects and subjects showing a percentage change in cartilage signal were included in the imaging results.
MRIs were obtained post-operatively at Day 10, obtained during the time period of Day 10 through Week 52, and again obtained during the time period of Week 52 through Week 104/ET). The images were evaluated using ICRS assessments of chondral lesions to determine the percentage of change in cartilage lesions over time post-operatively. ICRS partial-thickness chondral lesion assessment scores: Low-grade defect = less than 50% High-grade defect = 50% to 99%
Outcome measures
| Measure |
Part II: RF-based Debridement
n=19 Participants
Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
|
Part II: Mechanical Debridement
n=28 Participants
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
Part II: Mechanical Debridement
n=29 Participants
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
|---|---|---|---|
|
Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments
Postop Day 10 (Baseline) - Percent (%) Lesion Fill
|
50.5 units on a scale
Standard Deviation 15.5
|
52.9 units on a scale
Standard Deviation 16.6
|
53.5 units on a scale
Standard Deviation 16.8
|
|
Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments
Day 10 to Week 52 - <50% Change in Lesion Fill
|
-0.3 units on a scale
Standard Deviation 8.1
|
-1.9 units on a scale
Standard Deviation 4.4
|
1.5 units on a scale
Standard Deviation 6.6
|
|
Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments
Day 10 to Week 52 - ≥50% Change in Lesion Fill
|
1.2 units on a scale
Standard Deviation 11.1
|
-3.4 units on a scale
Standard Deviation 5.9
|
-5.5 units on a scale
Standard Deviation 10.8
|
|
Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments
Weeks 52 to 104/ET - <50% Change in Lesion Fill
|
-5.2 units on a scale
Standard Deviation 13.4
|
2.9 units on a scale
Standard Deviation 8.8
|
-6.0 units on a scale
Standard Deviation 11.9
|
|
Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments
Weeks 52 to 104/ET - ≥50% Change in Lesion Fill
|
1.2 units on a scale
Standard Deviation 14.7
|
-3.4 units on a scale
Standard Deviation 8.6
|
3.7 units on a scale
Standard Deviation 4.7
|
Adverse Events
Part I
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Part II: RF-based Debridement
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Part II: Mechanical Debridement
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part I
n=19 participants at risk
Part I: All Investigators were required to perform 1 to 3 procedures using the study device to minimize variability relating to the technique recommended in the IFU. These subjects were followed per protocol and analyzed for safety findings only.
|
Part II: RF-based Debridement
n=28 participants at risk
Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
|
Part II: Mechanical Debridement
n=29 participants at risk
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
|---|---|---|---|
|
General disorders
Hernia
|
0.00%
0/19 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
3.6%
1/28 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/19 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
3.4%
1/29 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/19 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
3.6%
1/28 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
Other adverse events
| Measure |
Part I
n=19 participants at risk
Part I: All Investigators were required to perform 1 to 3 procedures using the study device to minimize variability relating to the technique recommended in the IFU. These subjects were followed per protocol and analyzed for safety findings only.
|
Part II: RF-based Debridement
n=28 participants at risk
Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself.
|
Part II: Mechanical Debridement
n=29 participants at risk
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions.
|
|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.3%
5/19 • Number of events 10 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
71.4%
20/28 • Number of events 27 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
44.8%
13/29 • Number of events 14 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
3.4%
1/29 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
2/19 • Number of events 2 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
7.1%
2/28 • Number of events 2 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
10.5%
2/19 • Number of events 2 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/19 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
7.1%
2/28 • Number of events 2 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
3.4%
1/29 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Infections and infestations
Pneumonia
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Psychiatric disorders
Depression
|
0.00%
0/19 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
7.1%
2/28 • Number of events 2 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
7.1%
2/28 • Number of events 2 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
6.9%
2/29 • Number of events 2 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/19 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
7.1%
2/28 • Number of events 2 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
General disorders
Oedema peripheral
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
3.6%
1/28 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
General disorders
Hernia Pain
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/19 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
10.7%
3/28 • Number of events 3 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
6.9%
2/29 • Number of events 2 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Investigations
Blood pressure increased
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
3.4%
1/29 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/19 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
6.9%
2/29 • Number of events 2 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/19 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
7.1%
2/28 • Number of events 2 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
10.5%
2/19 • Number of events 3 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
General disorders
Pyrexia
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Vascular disorders
Deep vein thrombosis
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
3.6%
1/28 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Infections and infestations
Cellulitis
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
7.1%
2/28 • Number of events 2 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
3.4%
1/29 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
3.4%
1/29 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.3%
1/19 • Number of events 1 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/28 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
0.00%
0/29 • AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.
|
Additional Information
Stephan Mangin, Director, Global Clinical Strategy
Smith & Nephew, Inc
Phone: M +1 (512) 913-8192
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Authorship and contents of publications shall be discussed between each Principal Investigator and Sponsor. Sponsor shall serve as coordinator of multi-center study disclosures and, in event of a disagreement among investigators, Sponsor shall determine resolution of any such dispute. Sponsor shall be furnished copies of any proposed multi-center publication or disclosure at least 90 days prior to the proposed date for submission for publication or disclosure.
- Publication restrictions are in place
Restriction type: OTHER