Trial Outcomes & Findings for Comparison of BioCartilage Versus Marrow Stimulating Procedure for Cartilage Defects of the Knee (NCT NCT02203071)
NCT ID: NCT02203071
Last Updated: 2020-03-16
Results Overview
The primary endpoint is to determine whether subjects receiving a marrow stimulating procedure (MSP) augmented with BioCartilage have improved outcomes (MRI) compared to subjects who receive MSP without the use of BioCartilage. Quantitative (%fill) and qualitative (tissue quality) MRI assessments of repair tissue will be performed by a musculoskeletal (MSK) radiologist who is blinded to treatment group, and compared for differences between treatment groups.
COMPLETED
25 participants
1 year post-operatively
2020-03-16
Participant Flow
6 Subjects were intra-operative screen failures.
Participant milestones
| Measure |
MSP With BioCartilage
Patients receiving marrow stimulating procedure with BioCartilage adjunct.
|
MSP Without BioCartilage
Patients receiving marrow stimulating procedure without BioCartilage.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
6
|
|
Overall Study
COMPLETED
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
MSP With BioCartilage
Patients receiving marrow stimulating procedure with BioCartilage adjunct.
|
MSP Without BioCartilage
Patients receiving marrow stimulating procedure without BioCartilage.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MSP Without BioCartilage
n=6 Participants
Patients receiving marrow stimulating procedure without BioCartilage.
|
MSP With BioCartilage
n=13 Participants
Patients receiving marrow stimulating procedure with BioCartilage adjunct.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=19 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=6 Participants
|
12 Participants
n=13 Participants
|
18 Participants
n=19 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
1 Participants
n=13 Participants
|
1 Participants
n=19 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=6 Participants
|
6 Participants
n=13 Participants
|
11 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=6 Participants
|
7 Participants
n=13 Participants
|
8 Participants
n=19 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants
|
13 participants
n=13 Participants
|
19 participants
n=19 Participants
|
|
BMI (Body Mass Index)
|
31.2 kg/m^2
n=6 Participants
|
30.6 kg/m^2
n=13 Participants
|
30.8 kg/m^2
n=19 Participants
|
PRIMARY outcome
Timeframe: 1 year post-operativelyPopulation: There were 6 screen fails and 10 enrolled subjects who did not complete the study. Fifteen patients who were screened, consented, and enrolled, completed the 2-year study. Five patients who completed the study were assigned to the MSP treatment group and ten were assigned to the BioCartilage treatment group.
The primary endpoint is to determine whether subjects receiving a marrow stimulating procedure (MSP) augmented with BioCartilage have improved outcomes (MRI) compared to subjects who receive MSP without the use of BioCartilage. Quantitative (%fill) and qualitative (tissue quality) MRI assessments of repair tissue will be performed by a musculoskeletal (MSK) radiologist who is blinded to treatment group, and compared for differences between treatment groups.
Outcome measures
| Measure |
MSP With BioCartilage
n=13 Participants
Patients receiving marrow stimulating procedure with BioCartilage adjunct.
|
MSP Without BioCartilage
n=6 Participants
Patients receiving marrow stimulating procedure without BioCartilage.
|
|---|---|---|
|
MRI Repair Tissue Comparison
>50% fill, isointense
|
10 Participants
|
2 Participants
|
|
MRI Repair Tissue Comparison
<50% fill, non-isointense
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Approximately 2 yearsPopulation: There were 6 screen fails and 10 enrolled subjects who did not complete the study. Fifteen patients who were screened, consented, and enrolled, completed the 2-year study. Five patients who completed the study were assigned to the MSP treatment group and ten were assigned to the BioCartilage treatment group.
The 12-item Short Form Survey (SF-12) is a general health questionnaire. The SF-12 was constructed using questions drawn from each of the 8 dimensions of the MOS 36 item Short Form Survey (SF-36). It is designed to have similar performance to the SF-36, while taking less time to complete. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Outcome measures
| Measure |
MSP With BioCartilage
n=10 Participants
Patients receiving marrow stimulating procedure with BioCartilage adjunct.
|
MSP Without BioCartilage
n=5 Participants
Patients receiving marrow stimulating procedure without BioCartilage.
|
|---|---|---|
|
Short Form-12 Health Survey (SF-12)
Physical Health Composite Scores
|
51.4 score on a scale
Standard Deviation 7
|
43.4 score on a scale
Standard Deviation 10
|
|
Short Form-12 Health Survey (SF-12)
Mental Health Composite Scores
|
56.1 score on a scale
Standard Deviation 7
|
59.2 score on a scale
Standard Deviation 4.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 2 yearsPopulation: There were 6 screen fails and 10 enrolled subjects who did not complete the study. Fifteen patients who were screened, consented, and enrolled, completed the 2-year study. Five patients who completed the study were assigned to the MSP treatment group and ten were assigned to the BioCartilage treatment group.
The Marx Scale consists of four questions concerning four activities or actions: running, cutting, deceleration, and pivoting. The patient or survey respondent is asked to report on the frequency with which they performed the activity in their healthiest state within the past year. The four knee functions are rated on a 5-point scale of frequency and scores are added up to a minimum score of 0 and a maximum of 16 points, with a higher score indicating more frequent participation.
Outcome measures
| Measure |
MSP With BioCartilage
n=10 Participants
Patients receiving marrow stimulating procedure with BioCartilage adjunct.
|
MSP Without BioCartilage
n=5 Participants
Patients receiving marrow stimulating procedure without BioCartilage.
|
|---|---|---|
|
Marx Activity Rating Scale
|
9.5 score on a scale
Standard Deviation 5
|
3.4 score on a scale
Standard Deviation 4.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 2 yearsPopulation: There were 6 screen fails and 10 enrolled subjects who did not complete the study. Fifteen patients who were screened, consented, and enrolled, completed the 2-year study. Five patients who completed the study were assigned to the MSP treatment group and ten were assigned to the BioCartilage treatment group.
The Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment.
Outcome measures
| Measure |
MSP With BioCartilage
n=10 Participants
Patients receiving marrow stimulating procedure with BioCartilage adjunct.
|
MSP Without BioCartilage
n=5 Participants
Patients receiving marrow stimulating procedure without BioCartilage.
|
|---|---|---|
|
Knee Injury and Osteoarthritis Outcomes Score (KOOS)
|
85.9 score on a scale
Standard Deviation 12
|
71.6 score on a scale
Standard Deviation 18
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 2 yearsPopulation: There were 6 screen fails and 10 enrolled subjects who did not complete the study. Fifteen patients who were screened, consented, and enrolled, completed the 2-year study. Five patients who completed the study were assigned to the MSP treatment group and ten were assigned to the BioCartilage treatment group.
The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Meanwhile, the sports activity subscale focuses on functions like going up and down the stairs, rising from a chair, squatting and jumping. The knee function subscale asks patients one simple question: how is their knee at present versus how was their knee prior to injury? Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
Outcome measures
| Measure |
MSP With BioCartilage
n=10 Participants
Patients receiving marrow stimulating procedure with BioCartilage adjunct.
|
MSP Without BioCartilage
n=5 Participants
Patients receiving marrow stimulating procedure without BioCartilage.
|
|---|---|---|
|
International Knee Documentation Committee (IKDC) Subjective Portion
|
76.7 score on a scale
Standard Deviation 13.3
|
68.9 score on a scale
Standard Deviation 22.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 2 yearsPopulation: There were 6 screen fails and 10 enrolled subjects who did not complete the study. Fifteen patients who were screened, consented, and enrolled, completed the 2-year study. Five patients who completed the study were assigned to the MSP treatment group and ten were assigned to the BioCartilage treatment group.
This is a two question survey administered to subjects that obtains subjective data "Yes / No" regarding whether the subject has been able to return to work or sports activity since surgery.
Outcome measures
| Measure |
MSP With BioCartilage
n=10 Participants
Patients receiving marrow stimulating procedure with BioCartilage adjunct.
|
MSP Without BioCartilage
n=5 Participants
Patients receiving marrow stimulating procedure without BioCartilage.
|
|---|---|---|
|
Number of Participants Who Were Able To Return To Return to Work or Sports Activity
|
9 Participants
|
4 Participants
|
Adverse Events
MSP With BioCartilage
MSP Without BioCartilage
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