N/A
N=67
Follow-Up Study Evaluating The Long Term Safety and Efficacy of BST-CarGel and Microfracture Repair of the Knee
Knee Injuries
Bottom Line
View on ClinicalTrials.gov: NCT01246895 ↗Enrolled (actual)
67
Serious AEs
1.5%
Results posted
Jan 2018
Primary outcome: Primary: Degree of Lesion Filling (%Fill) by Repair Tissue at Degree of Lesion Filling (%Fill) by Repair Tissue at 5 Years Through MRI. — 93.79; 86.96 Percentage of lesion filled (%) — p=0.017
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Microfracture with BST-CarGel (Device); Microfracture without BST-CarGel (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Piramal Healthcare Canada Ltd
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Degree of Lesion Filling (%Fill) by Repair Tissue at Degree of Lesion Filling (%Fill) by Repair Tissue at 5 Years Through MRI. |
93.79; 86.96 | 0.017 sig |
| PRIMARY Repair Tissue Quality (T2 MRI) |
75.68; 90.41 | 0.026 sig |
| SECONDARY Percentage Change From Baseline for Knee-related Pain, Stiffness and Function at 5 Years (WOMAC Parts A, B, C) |
-15.37; -16.56; -5.63; -6.68; -56.52; -62.10 | 0.474 |
| SECONDARY The Number of Participants With Adverse Events Until 5 Years |
13; 18; 1; 0; 1; 2 | 0.01 sig |
Summary
This follow-up study will evaluate the effects of BST-CarGel® application to a microfractured lesion (investigational) and microfracture alone (control) for up to 5 years from treatment in subjects, treated under Protocols CG-CIP01-P and CG-CIP02-P, and will serve as a post approval study for these Protocols, in support of a commercial application. The lesions treated under Protocols CG-CIP01-P and CG-CIP02-P were focal lesions of articular cartilage, grade 3 or 4 (either ICRS or Outerbridge classification) on the medial and lateral femoral condyles of the knee, and were classified as either acute or chronic.
Eligibility Criteria
Inclusion Criteria
- The subject was treated under Protocol CG-CIP01 or CG-CIP02 and completed 12 month follow-up period
- The subject has understood and signed a Research Ethics Board(REB) approved Informed Consent Form (ICF)
Exclusion Criteria
- The subject was not treated under Protocol CG-CIP01-P or CG-CIP02-P
- The subject did not complete 12 month follow-up period
Data sourced from ClinicalTrials.gov (NCT01246895). 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.