N/A
N=80
Trial Comparing BST-CarGel and Microfracture in Repair of Articular Cartilage Lesions in the Knee
Knee Injuries
Bottom Line
View on ClinicalTrials.gov: NCT00314236 ↗Enrolled (actual)
80
Serious AEs
7.5%
Results posted
Dec 2015
Primary outcome: Primary: Degree of Filling of the Lesion by Repair Tissue at 12 Months Through MRI. — 92.81; 85.22 Percentage of lesion fill — p=0.011
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BST-CarGel with Microfracture (Device); Microfracture without BST-CarGel (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Piramal Healthcare Canada Ltd
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Degree of Filling of the Lesion by Repair Tissue at 12 Months Through MRI. |
92.81; 85.22 | 0.011 sig |
| PRIMARY Repair Cartilage T2 Relaxation Time |
70.46; 85.04 | 0.033 sig |
| SECONDARY Change From Baseline for Knee-related Pain, Stiffness and Function at 12 Months (WOMAC Parts A, B, C) |
-16.16; -16.91; -5.97; -6.56; -55.96; -60.59 | — |
| SECONDARY Frequency of Adverse Events Between Study Groups |
97.6; 92.3 | — |
Summary
This study will investigate whether the treatment of damaged cartilage in the knee with BST-CarGel will increase the amount and quality of cartilage repair tissue when compared with microfracture alone. Furthermore, the effect of BST-CarGel in decreasing cartilage related pain and improving cartilage-related function in the knee will be assessed.
Eligibility Criteria
Inclusion Criteria
- Between 18 and 55 years of age
- Focal articular cartilage lesion on the medial femoral condyle
- Grade 3 or 4 acute (traumatic) or chronic (degenerative) lesion
- Stable knee
Exclusion Criteria
- Multiple lesions or kissing lesions
- Clinically relevant compartment malalignment (> 5 degrees)
- Undergone ligament treatments in the affected knee within 2 years prior to trial
- Inflammatory arthropathy, such as rheumatoid arthritis, systemic lupus, or active gout
- Previous surgical cartilage treatments in the affected knee in the last 12 months
Data sourced from ClinicalTrials.gov (NCT00314236). 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.