Trial Comparing BST-CarGel and Microfracture in Repair of Articular Cartilage Lesions in the Knee

Piramal

Status: Completed

Conditions: Knee Injuries

Treatments: Procedure: Microfracture without BST-CarGel; Device: BST-CarGel with Microfracture

Study type: Interventional

Funder types: Industry

Identifiers

NCT00314236

CG-CIP01-P

Details and patient eligibility

About

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.

Full description

Cartilage repair currently remains a problematic orthopedic concern with no effective solution. The development of new surgical techniques or therapies is critical in meeting this medical need.

This Canadian trial will be a pivotal protocol study, conducted as a randomized, controlled trial. A total of 80 subjects, 40 subjects in each of the two groups (BST-CarGel applied to a microfractured lesion or microfracture alone), will be enrolled in this study. The subjects and investigative medical staff will not be blinded to treatment due to the difference in surgical incision size. However, although the treatment will not be blinded, the primary effectiveness assessment will be blinded. The primary endpoint of this study will be cartilage repair at 12 months proved by demonstrating that BST-CarGel treatment effectively fills cartilage lesions with high quality cartilaginous tissue. The secondary endpoints will be pain, stiffness and function while other tertiary endpoints will include safety, quality-of-life (QOL), as well as macroscopic characterizations of tissue repair. The primary measure of this study will occur at 12 months, when imaging of repair tissue using magnetic resonance (MR) and associated analyses will compare tissue volume, quality and other anatomical variables. Radiographic evaluations will be blinded. Volunteer biopsies at 13 months may be obtained. Pain, stiffness, function and QOL will be assessed prior to treatment, and at 3, 6 and 12 months following treatment using self-administered validated scores (WOMAC and SF-36). In addition, subject safety will be assessed through a record of adverse events.

Enrollment: 80 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Microfracture with BST-CarGel

Experimental group

Description:

BST-CarGel applied to a Microfractured lesion in repair of focal articular cartilage lesions on the femoral condyle

Treatment:

Device: BST-CarGel with Microfracture

Microfracture without BST-CarGel

Active Comparator group

Description:

Microfractured lesion in repair of focal articular cartilage lesions on the femoral condyle

Treatment:

Procedure: Microfracture without BST-CarGel