Trial Comparing BST-CarGel and Microfracture in Repair of Articular Cartilage Lesions in the Knee
NCT ID: NCT00314236
Last Updated: 2015-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2005-12-31
2011-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Microfracture with BST-CarGel
BST-CarGel applied to a Microfractured lesion in repair of focal articular cartilage lesions on the femoral condyle
BST-CarGel with Microfracture
Microfracture performed with BST-CarGel added to the treated defect
Microfracture without BST-CarGel
Microfractured lesion in repair of focal articular cartilage lesions on the femoral condyle
Microfracture without BST-CarGel
Microfracture performed without BST-CarGel added to the treated defect.
Interventions
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BST-CarGel with Microfracture
Microfracture performed with BST-CarGel added to the treated defect
Microfracture without BST-CarGel
Microfracture performed without BST-CarGel added to the treated defect.
Eligibility Criteria
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Inclusion Criteria
* Focal articular cartilage lesion on the medial femoral condyle
* Grade 3 or 4 acute (traumatic) or chronic (degenerative) lesion
* Stable knee
Exclusion Criteria
* 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
18 Years
55 Years
ALL
No
Sponsors
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Piramal Healthcare Canada Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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William Stanish, MD
Role: PRINCIPAL_INVESTIGATOR
Orthopaedic and Sport Medicine - Dalhousie University
Locations
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Sports Medicine Centre - University of Calgary
Calgary, Alberta, Canada
New West Sports Medicine
New Westminster, British Columbia, Canada
Hospital at UBC
Vancouver, British Columbia, Canada
Pan Am Clinic
Winnipeg, Manitoba, Canada
Orthopaedic and Sport Medicine Clinic of Nova Scotia
Halifax, Nova Scotia, Canada
Entralogix Clinical Group Inc.
Newmarket, Ontario, Canada
Sports Medicine Clinic - Carleton University
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre, Div. of Orthopaedic Surgery
Toronto, Ontario, Canada
Hopital Charles LeMoyne
Greenfield Park, Quebec, Canada
Hospital Sacré-Coeur de Montréal
Montreal, Quebec, Canada
Centre Hospitalier Affilie Universitaire de Quebec et Hôpital Valcartier
Québec, Quebec, Canada
Seoul National University Hospital
Seoul, , South Korea
Kyung Hee University Medical Center
Seoul, , South Korea
Hospital Clinic i Provincial de Barcelona
Barcelona, Barcelona, Spain
Hospital Universitario Gregorio Maraňón
Madrid, Madrid, Spain
Hospital La Paz
Madrid, Madrid, Spain
FREMAP Centro de Prevención y Rehabilitación
Majadahonda, Madrid, Spain
Hospital Begona de Gijon
Gijón, Principality of Asturias, Spain
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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CG-CIP01-P
Identifier Type: -
Identifier Source: org_study_id