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

Not Applicable

Completed

Conditions: Knee Injuries

Interventions: Device: BST-CarGel with Microfracture
Procedure: Microfracture without BST-CarGel

Registration Number: NCT00314236

Lead Sponsor: Piramal Healthcare Canada Ltd

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microfracture with BST-CarGel	BST-CarGel with Microfracture	BST-CarGel applied to a Microfractured lesion in repair of focal articular cartilage lesions on the femoral condyle
Microfracture without BST-CarGel	Microfracture without BST-CarGel	Microfractured lesion in repair of focal articular cartilage lesions on the femoral condyle

Primary Outcome Measures

Name	Time	Method
Repair Cartilage T2 Relaxation Time	12 months	Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the repair tissue quality of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI T2 mapping. T2 maps are created by calculating the T2 relaxation times for repair tissue and cartilage plates for every voxel (picture element of a MRI scan containing the average signal information of a specific spatial location of the imaged body).
Degree of Filling of the Lesion by Repair Tissue at 12 Months Through MRI.	12 months	Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the degree of lesion filling of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI scans. The MR images will be acquired using high resolution 3D cartilage imaging sequences, so-called cartilage morphology sequences.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline for Knee-related Pain, Stiffness and Function at 12 Months (WOMAC Parts A, B, C)	12 months	The three sub-scales: 1) Pain, 2.) stiffness and 3.) function scores ranged from 0-10. Pain had 5 items and stiffness had 2 items, and function had 17 items. The total score for pain ranged from 0 no pain to 50 worst pain. The total score for stiffness ranged from 0 no stiffness to 20 worst stiffness. The total score for function raged from 0 no function to 170 worst function.
Frequency of Adverse Events Between Study Groups	12 months

Trial Locations

Locations (18): Hospital Sacré-Coeur de Montréal
🇨🇦
Montreal, Quebec, Canada
Hospital Begona de Gijon
🇪🇸
Gijon, Asturias, Spain
Seoul National University Hospital
🇰🇷
Seoul, Korea, Republic of
Orthopaedic and Sport Medicine Clinic of Nova Scotia
🇨🇦
Halifax, Nova Scotia, Canada
Sports Medicine Centre - University of Calgary
🇨🇦
Calgary, Alberta, Canada
Kyung Hee University Medical Center
🇰🇷
Seoul, Korea, Republic of
Centre Hospitalier Affilie Universitaire de Quebec et Hôpital Valcartier
🇨🇦
Quebec, Canada
FREMAP Centro de Prevención y Rehabilitación
🇪🇸
Majadahonda, Madrid, Spain
New West Sports Medicine
🇨🇦
New Westminster, British Columbia, Canada
Hospital La Paz
🇪🇸
Madrid, Spain
Hospital Clinic i Provincial de Barcelona
🇪🇸
Barcelona, Spain
Entralogix Clinical Group Inc.
🇨🇦
Newmarket, Ontario, Canada
Sports Medicine Clinic - Carleton University
🇨🇦
Ottawa, Ontario, Canada
Pan Am Clinic
🇨🇦
Winnipeg, Manitoba, Canada
Hopital Charles LeMoyne
🇨🇦
Greenfield Park, Quebec, Canada
Sunnybrook Health Sciences Centre, Div. of Orthopaedic Surgery
🇨🇦
Toronto, Ontario, Canada
Hospital Universitario Gregorio Maraňón
🇪🇸
Madrid, Spain
Hospital at UBC
🇨🇦
Vancouver, British Columbia, Canada