N/A
N=19
Comparison of BioCartilage Versus Marrow Stimulating Procedure for Cartilage Defects of the Knee
Defect of Articular Cartilage
Bottom Line
View on ClinicalTrials.gov: NCT02203071 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: MRI Repair Tissue Comparison — 10; 2; 3; 4 Participants — p=0.61
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Missouri-Columbia
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MRI Repair Tissue Comparison |
10; 2; 3; 4 | 0.61 |
| SECONDARY Short Form-12 Health Survey (SF-12) |
51.4; 43.4; 56.1; 59.2 | .001 sig |
Summary
Subjects will be selected among the investigators' patient population who are already scheduled to receive a marrow stimulating procedure (MSP), with or without the addition of BioCartilage.
During the surgical operation for MSP, a portion of the patient's blood is taken out and used to form a patch to cover a cartilage defect of the knee. Currently it is considered standard of care to either form the patch using only a portion of the patient's blood, or form the patch using a portion of the patient's blood combined with an FDA-approved augmentation such as BioCartilage.
This study will collect outcomes data and MRI for patients that are undergoing MSP with and without BioCartilage augmentation, then compare the data between those who received BioCartilage and those who did not.
The primary endpoint is to determine whether subjects receiving a marrow stimulating procedure (MSP) augmented with BioCartilage have improved outcomes (measured using quality of life indicators, functional outcomes, and MRI) compared to subjects who receive MSP without the use of BioCartilage.
Eligibility Criteria
Inclusion Criteria
I. Inclusion in the study will be considered when all of the following conditions are met:
- The subject is a candidate for the use of a MSP with microfracture and PRP, with or without augmentation with BioCartilage, for treatment of a focal defect of the knee (trochlea or femoral condyle).
- The subject is 18-years of age or greater
- The subject is able and willing to consent to participate in the study
- The subject is expected to be able to safely undergo MRI at the 1-year follow-up visit (no contraindications present, such as metal implants)
- Infection or inflammatory arthropathy (such as rheumatoid arthritis) is absent in the operative knee
Exclusion Criteria
II. Exclusion from the study will be determined by any one of the following conditions being met:
- The subject is undergoing bilateral knee surgery
- The subject is unwilling, or unable to consent due to psychiatric condition or legal incompetence
- The subject is either pregnant, or a prisoner
Data sourced from ClinicalTrials.gov (NCT02203071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.