Trial Outcomes & Findings for Steroid Injection vs. BioDRestore for Patients With Knee OA (NCT NCT02767492)
NCT ID: NCT02767492
Last Updated: 2021-11-23
Results Overview
Patient reported level of pain on a scale of 0-10, with 10 being extreme pain and 0 being no pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
Surgery through 12 months post-op/
Results posted on
2021-11-23
Participant Flow
Participant milestones
| Measure |
BioDRestore™
BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint.
BioD Restore: Investigational product, BioD Restore, will be injected into the articular space of the knee.
|
Corticosteroid
Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint.
Kenalog: Active comparator, Kenalog steroid, will be injected into the articular space of the knee.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Steroid Injection vs. BioDRestore for Patients With Knee OA
Baseline characteristics by cohort
| Measure |
BioDRestore™
n=45 Participants
BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint.
BioD Restore: Investigational product, BioD Restore, will be injected into the articular space of the knee.
|
Corticosteroid
n=45 Participants
Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint.
Kenalog: Active comparator, Kenalog steroid, will be injected into the articular space of the knee.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Continuous
|
61.86 years
STANDARD_DEVIATION 8.98 • n=5 Participants
|
64.03 years
STANDARD_DEVIATION 8.92 • n=7 Participants
|
62.92 years
STANDARD_DEVIATION 8.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
45 participants
n=7 Participants
|
90 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Surgery through 12 months post-op/Patient reported level of pain on a scale of 0-10, with 10 being extreme pain and 0 being no pain.
Outcome measures
| Measure |
BioDRestore™
n=35 Participants
BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint.
BioD Restore: Investigational product, BioD Restore, will be injected into the articular space of the knee.
|
Corticosteroid
n=35 Participants
Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint.
Kenalog: Active comparator, Kenalog steroid, will be injected into the articular space of the knee.
|
|---|---|---|
|
Visual Analog Pain Score
|
2.49 score on a scale
Standard Deviation 2.41
|
3.25 score on a scale
Standard Deviation 2.82
|
PRIMARY outcome
Timeframe: Sugery to 12 months post-opPatient reported quality of life. Score contains a physical component and mental component score. Both scales are continuous and values range from 0 to 70, with higher scoring indicating higher physical and mental component scores
Outcome measures
| Measure |
BioDRestore™
n=35 Participants
BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint.
BioD Restore: Investigational product, BioD Restore, will be injected into the articular space of the knee.
|
Corticosteroid
n=35 Participants
Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint.
Kenalog: Active comparator, Kenalog steroid, will be injected into the articular space of the knee.
|
|---|---|---|
|
Veterans Rand 12 Item Health Survey
|
56.95 score on a scale
Standard Deviation 9.84
|
58.01 score on a scale
Standard Deviation 7.49
|
PRIMARY outcome
Timeframe: Surgery to 12 months post-op.Patient reported knee function scores on a scale of 0-100, with 100 being a excellent outcome indicating no symptoms.
Outcome measures
| Measure |
BioDRestore™
n=35 Participants
BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint.
BioD Restore: Investigational product, BioD Restore, will be injected into the articular space of the knee.
|
Corticosteroid
n=35 Participants
Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint.
Kenalog: Active comparator, Kenalog steroid, will be injected into the articular space of the knee.
|
|---|---|---|
|
Lysholm Knee Score
|
75.26 score on a scale
Standard Deviation 17.75
|
61.00 score on a scale
Standard Deviation 22.00
|
PRIMARY outcome
Timeframe: Surgery to 12 months post-op.Percentage of normal for affected knee between 0 to 100, with 100 being a perfectly "normal" knee and 0 being a completely "abnormal" knee.
Outcome measures
| Measure |
BioDRestore™
n=35 Participants
BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint.
BioD Restore: Investigational product, BioD Restore, will be injected into the articular space of the knee.
|
Corticosteroid
n=35 Participants
Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint.
Kenalog: Active comparator, Kenalog steroid, will be injected into the articular space of the knee.
|
|---|---|---|
|
Single Alpha Numeric Evaluation (SANE)
|
66.14 score on a scale
Standard Deviation 23.27
|
60.49 score on a scale
Standard Deviation 25.37
|
PRIMARY outcome
Timeframe: Surgery to 12 months post opKnee outcome measure assessed via Knee Injury and Osteoarthritis Outcome Score (KOOS) on a scale of 0 to 100. The higher score of 100 indicates a fully functional knee without knee pain or problems.
Outcome measures
| Measure |
BioDRestore™
n=35 Participants
BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint.
BioD Restore: Investigational product, BioD Restore, will be injected into the articular space of the knee.
|
Corticosteroid
n=35 Participants
Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint.
Kenalog: Active comparator, Kenalog steroid, will be injected into the articular space of the knee.
|
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
|
64.10 score on a scale
Standard Deviation 21.23
|
55.67 score on a scale
Standard Deviation 22.23
|
Adverse Events
BioDRestore™
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Corticosteroid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place