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

This study has been completed.
Sponsor:
Information provided by:
Piramal Healthcare Canada Ltd
ClinicalTrials.gov Identifier:
NCT00314236
First received: April 11, 2006
Last updated: August 17, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Knee Injuries
Device: BST-CarGel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Comparative Multicenter Clinical Trial Evaluating BST-CarGel™ and Microfracture in Repair of Focal Articular Cartilage Lesions on the Femoral Condyle

Resource links provided by NLM:


Further study details as provided by Piramal Healthcare Canada Ltd:

Primary Outcome Measures:
  • degree of filling of the lesion by repair tissue at 12 months through delayed gadolinium enhanced magnetic resonance imaging of cartilage (dGEMRIC) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • repair tissue quality at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Knee-related pain, stiffness and function at 12 months (WOMAC parts A, B, C) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse events between study groups [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: December 2005
Study Completion Date: May 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Microfracture performed with BST-CarGel added to the treated defect
Device: BST-CarGel
Microfracture performed with BST-CarGel added to the treated defect
Active Comparator: 2
Microfracture alone performed to the treated defect
Device: BST-CarGel
Microfracture performed without BST-CarGel added to the treated defect.

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314236

Locations
Canada, Alberta
Sports Medicine Centre - University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Red Deer Medical Center
Red Deer, Alberta, Canada, T4N 6V7
Canada, British Columbia
New West Sports Medicine
New Westminster, British Columbia, Canada, V3L 5P5
Hospital at UBC
Vancouver, British Columbia, Canada, V6T 1Z3
Canada, Manitoba
Pan Am Clinic
Winnipeg, Manitoba, Canada, R3M 3E4
Canada, Nova Scotia
Orthopaedic and Sport Medicine Clinic of Nova Scotia
Halifax, Nova Scotia, Canada, B3H 4M2
Canada, Ontario
Etobicoke General Hospital
Etobicoke, Ontario, Canada, M9V 4B8
Hamilton Health Sciences
Hamilton, Ontario, Canada, L9C 7N4
Associate Professor Department of Surgery Fowler Kennedy Sport Medecine Clinic
London, Ontario, Canada, N6A 3K7
Entralogix Clinical Group Inc.
Newmarket, Ontario, Canada, V6T 2B5
Sports Medicine Clinic - Carleton University
Ottawa, Ontario, Canada, K1S 5B6
Sunnybrook Health Sciences Centre, Div. of Orthopaedic Surgery
Toronto, Ontario, Canada, M3N 3M5
The Sports Medicine Specialists
Toronto, Ontario, Canada, M4P 1E8
Canada, Quebec
Hopital Charles LeMoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Hospital Sacré-Coeur de Montréal
Montreal, Quebec, Canada, H4J 1C5
Hôpital Maisonneuve-Rosemont
Montréal, Quebec, Canada, H1T 2M4
Centre Hospitalier St-Eustache
St-Eustache, Quebec, Canada, J7R 5B1
Canada
Centre Hospitalier Affilie Universitaire de Quebec et Hôpital Valcartier
Quebec, Canada, G1J 1Z4
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Kyung Hee University Medical Center
Seoul, Korea, Republic of, 130-702
Spain
Hospital Begona de Gijon
Gijon, Asturias, Spain, 33204
FREMAP Centro de Prevención y Rehabilitación
Majadahonda, Madrid, Spain, 28220
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital de La Esperanza
Barcelona, Spain, 08024
Hospital Universitario Gregorio Maraňón
Madrid, Spain, 28034
Hospital La Paz
Madrid, Spain
Sponsors and Collaborators
Piramal Healthcare Canada Ltd
Investigators
Principal Investigator: William Stanish, MD Orthopaedic and Sport Medicine - Dalhousie University
  More Information

Publications:
Responsible Party: Alberto Restrepo, Director Medical Affairs, Piramal HealthCare (Canada) Ltd.
ClinicalTrials.gov Identifier: NCT00314236     History of Changes
Other Study ID Numbers: CG-CIP01-P
Study First Received: April 11, 2006
Last Updated: August 17, 2011
Health Authority: Canada: Health Canada
Spain: Ministry of Health

Keywords provided by Piramal Healthcare Canada Ltd:
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

Additional relevant MeSH terms:
Knee Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 16, 2014