Clinical trial NCT00314236: Trial Comparing BST-CarGel and Microfracture in Repair of Articular Cartilage Lesions in the Knee
Official title: A Randomized, Comparative Multicenter Clinical Trial Evaluating BST-CarGel™ and Microfracture in Repair of Focal Articular Cartilage Lesions on the Femoral Condyle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Injuries
Keywords: Cartilage repair
Cartilage
Knee
Knee Pain
Microfracture
arthroscopy
bone marrow stimulation
Chondrogenesis
Scaffold
Chitosan
A02.165.165
A10.165.382.332
G07.574.500.325.377.625.180
A10.165.382.400
Articular Cartilage Repair
Lead sponsor: Piramal Healthcare Canada Ltd
Sponsor class: INDUSTRY
First posted: 2006-04-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Degree of Filling of the Lesion by Repair Tissue at 12 Months Through MRI.
timeFrame: 12 months
measure: Repair Cartilage T2 Relaxation Time
timeFrame: 12 months
Secondary outcomes:
measure: Change From Baseline for Knee-related Pain, Stiffness and Function at 12 Months (WOMAC Parts A, B, C)
timeFrame: 12 months
measure: Frequency of Adverse Events Between Study Groups
timeFrame: 12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Sports Medicine Centre - University of Calgary
state: Alberta
city: New Westminster
country: Canada
facility: New West Sports Medicine
state: British Columbia
city: Vancouver
country: Canada
facility: Hospital at UBC
state: British Columbia
city: Winnipeg
country: Canada
facility: Pan Am Clinic
state: Manitoba
city: Halifax
country: Canada
facility: Orthopaedic and Sport Medicine Clinic of Nova Scotia
state: Nova Scotia
city: Newmarket
country: Canada
facility: Entralogix Clinical Group Inc.
state: Ontario
city: Ottawa
country: Canada
facility: Sports Medicine Clinic - Carleton University
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre, Div. of Orthopaedic Surgery
state: Ontario
city: Greenfield Park
country: Canada
facility: Hopital Charles LeMoyne
state: Quebec
city: Montreal
country: Canada
facility: Hospital Sacré-Coeur de Montréal
state: Quebec
city: Quebec
country: Canada
facility: Centre Hospitalier Affilie Universitaire de Quebec et Hôpital Valcartier
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
city: Gijon
country: Spain
facility: Hospital Begona de Gijon
state: Asturias
city: Majadahonda
country: Spain
facility: FREMAP Centro de Prevención y Rehabilitación
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Maraňón
city: Madrid
country: Spain
facility: Hospital La Paz
Study officials:
affiliation: Orthopaedic and Sport Medicine - Dalhousie University
name: William Stanish, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoemann CD, Hurtig M, Rossomacha E, Sun J, Chevrier A, Shive MS, Buschmann MD. Chitosan-glycerol phosphate/blood implants improve hyaline cartilage repair in ovine microfracture defects. J Bone Joint Surg Am. 2005 Dec;87(12):2671-2686. doi: 10.2106/JBJS.D.02536.
citation: Chevrier A, Hoemann CD, Sun J, Buschmann MD. Chitosan-glycerol phosphate/blood implants increase cell recruitment, transient vascularization and subchondral bone remodeling in drilled cartilage defects. Osteoarthritis Cartilage. 2007 Mar;15(3):316-27. doi: 10.1016/j.joca.2006.08.007. Epub 2006 Sep 26.
citation: Hoemann CD, Sun J, McKee MD, Chevrier A, Rossomacha E, Rivard GE, Hurtig M, Buschmann MD. Chitosan-glycerol phosphate/blood implants elicit hyaline cartilage repair integrated with porous subchondral bone in microdrilled rabbit defects. Osteoarthritis Cartilage. 2007 Jan;15(1):78-89. doi: 10.1016/j.joca.2006.06.015. Epub 2006 Aug 8.
citation: Stanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Restrepo A, Shive MS. Novel scaffold-based BST-CarGel treatment results in superior cartilage repair compared with microfracture in a randomized controlled trial. J Bone Joint Surg Am. 2013 Sep 18;95(18):1640-50. doi: 10.2106/JBJS.L.01345.