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

This study is currently recruiting participants.
Verified by BioSyntech Canada Inc., April 2008

Sponsored by: BioSyntech Canada Inc.
Information provided by: BioSyntech Canada Inc.
ClinicalTrials.gov Identifier: NCT00314236
  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

MedlinePlus related topics:   Knee Injuries and Disorders   

Drug Information available for:   Chitosan   

U.S. FDA Resources

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

Further study details as provided by BioSyntech Canada Inc.:

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 ]

Estimated Enrollment:   80
Study Start Date:   December 2005
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Microfracture plus BST-CarGel
Device: BST-CarGel
Microfracture performed with BST-CarGel added to the treated defect
2: Active Comparator
Microfracture alone
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

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

Contacts
Contact: Richard Lacombe, PhD     450-686-2437 ext 231     richard.lacombe@biosyntech.com    
Contact: Ligia Stern     450-686-2437 ext 303     ligia.stern@biosyntech.com    

Locations
Canada
Centre Hospitalier Affilie Universitaire de Quebec et Hôpital Valcartier     Recruiting
      Quebec, Canada, G1J 1Z4
      Contact: Stephane Pelet, MD     418-649-5595        
      Contact: Helene Cote     418-649-0252 ext 3165        
      Principal Investigator: Stephane Pelet, MD            
      Sub-Investigator: Rejean Cloutier, MD            
      Sub-Investigator: Jean Lamontagne, MD            
      Sub-Investigator: Sylvain Belzile, MD            
Canada, Alberta
Sports Medicine Centre - University of Calgary     Recruiting
      Calgary, Alberta, Canada, T2N 1N4
      Contact: Nicholas Mohtadi, MD     403-220-5077        
      Contact: Denise Chan     403-220-8944        
      Principal Investigator: Nicholas Mohtadi, MD            
Canada, British Columbia
New West Sports Medicine     Recruiting
      New Westminster, British Columbia, Canada, V3L 5P5
      Contact: Robert McCormack, MD     604-526-7885        
      Contact: Mauri Zomar     604-520-4855        
      Principal Investigator: Robert McCormack            
Hospital at UBC     Recruiting
      Vancouver, British Columbia, Canada, V6T 1Z3
      Contact: Jordan Leith, MD     604-822-5601     jleith@shaw.ca    
      Contact: Cheryl Davies     604-875-5886     cheryl.davies@vch.ca    
      Principal Investigator: Jordan Leith, MD            
      Sub-Investigator: Dr. Gilbart            
      Sub-Investigator: William Regan            
      Sub-Investigator: Patrick Chin, MD            
Canada, Manitoba
Pan Am Clinic     Recruiting
      Winnipeg, Manitoba, Canada, R3M 3E4
      Contact: Peter MacDonald, MD     204-925-7490        
      Contact: Jeff Leiter     204-925-7469        
      Principal Investigator: Peter McDonald, MD            
      Sub-Investigator: Warren Froese, MD            
Canada, Nova Scotia
Orthopaedic and Sport Medicine Clinic of Nova Scotia     Recruiting
      Halifax, Nova Scotia, Canada, B3H 4M2
      Contact: William D Stanish, MD     902-421-7525        
      Contact: Donalda Dickey     902-473-2608        
      Principal Investigator: William D Stanish, MD            
Canada, Ontario
Sunnybrook Health Sciences Centre, Div. of Orthopaedic Surgery     Recruiting
      Toronto, Ontario, Canada, M3N 3M5
      Contact: Paul Marks, MD     416-480-6838        
      Contact: Monica Kunz     416-480-4083        
      Principal Investigator: Paul Marks, MD            
Hamilton Health Sciences     Recruiting
      Hamilton, Ontario, Canada, L9C 7N4
      Contact: Frank Smith, MD            
      Contact: Lilly-Ann Reynolds     905-521-2100        
      Principal Investigator: Devin Peterson, MD            
      Sub-Investigator: Rick Ogilive, MD            
      Sub-Investigator: David Wismer, MD            
      Sub-Investigator: Mitch Winemaker, MD            
Associate Professor Department of Surgery Fowler Kennedy Sport Medecine Clinic     Recruiting
      London, Ontario, Canada, N6A 3K7
      Contact: Robert Litchfield, MD     519-661-4156        
      Contact: Elizabeth Wambolt     519-661-2111 ext 87528        
      Principal Investigator: Robert Litchfield, MD            
      Sub-Investigator: Robert J Giffin, MD            
      Sub-Investigator: Marie-Eve Lebel, MD            
      Sub-Investigator: Kevin Willits, MD            
Entralogix Clinical Group Inc.     Recruiting
      Oakville, Ontario, Canada, L6J 3M5
      Contact: Paul Zalzal, MD     905-717-2090     trials@entralogix.com    
      Contact: Vito Losito     905-717-2090     vitolosito@entralogix.com    
      Principal Investigator: Paul Zalzal, MD            
      Sub-Investigator: Mark Guinty, MD            
      Sub-Investigator: Markus Bishoff, MD            
      Sub-Investigator: Robert Deacon, MD            
      Sub-Investigator: Brad Weening, MD            
Sports Medicine Clinic - Carleton University     Not yet recruiting
      Ottawa, Ontario, Canada, K1S 5B6
      Contact: Don Johnson, M.D.     613-520-3510     donnie@carletonsportsmed.com    
      Contact: Anna Fazekas Conway     613-737-8920     aconway@ottawahospital.on.ca    
      Principal Investigator: Don Johnson, M.D.            
      Sub-Investigator: S.L. Liew, M.D.            
Canada, Quebec
Hospital Sacré-Coeur de Montréal     Recruiting
      Montreal, Quebec, Canada, H4J 1C5
      Contact: Michel Malo, MD     514-338-2222        
      Contact: Marie-France Poirier     514-338-2222 ext 3465        
      Principal Investigator: Michel Malo, MD            
      Sub-Investigator: Julio Fernandez, MD            
Hopital Charles LeMoyne     Recruiting
      Greenfield Park, Quebec, Canada, J4V 2H1
      Contact: Jacques Desnoyers, MD     450-672-9305 ext 3106        
      Contact: Brigitte Lecours     450-466-5000 ext 3186        
      Principal Investigator: Jacques Desnoyers, MD            
Centre Hospitalier St-Eustache     Recruiting
      St-Eustache, Quebec, Canada, J7R 5B1
      Contact: Sébastien Guimond-Simard, MD     (450) 688-5132        
      Contact: Francine Clermont     (450) 473-7222        
      Principal Investigator: Sébastien Guimond-Simard, MD            
      Sub-Investigator: Pierre-André Clermont            
      Sub-Investigator: Garry Greenfield            
      Sub-Investigator: Pascale Vézina            
Hôpital Maisonneuve-Rosemont     Recruiting
      Montréal, Quebec, Canada, H1T 2M4
      Contact: Patrick Lavigne, MD     514-254-6161     lavignepatrick@hotmail.com    
      Contact: Sylvie Rochon     514-252-3400 ext 4428     srochon.hmr@ssss.gouv.qc.ca    
      Principal Investigator: Patrick Lavigne, MD            
      Sub-Investigator: David Blanchette, MD            
Korea, Republic of
Seoul National University Hospital     Not yet recruiting
      Seoul, Korea, Republic of, 110-744
      Contact: Myung Chul Lee, MD     011.9713.3215     leemc@snu.ac.kr    
      Contact: Nan-young Jung     011.9120.6148     sesillia5511@naver.com    
      Principal Investigator: Myoung Chul Lee, MD            
      Sub-Investigator: Sang-hoon Lee, MD            
      Sub-Investigator: Yong-seoup Han, MD            
      Sub-Investigator: Won-chul Choi, MD            
Kyung Hee University Medical Center     Not yet recruiting
      Seoul, Korea, Republic of, 130-702
      Contact: Kyoung-Ho Yoon, MD     011.305.5972     kyoungho@khmc.or.kr    
      Contact: Hyun-Jin Im     011.958.8359     ambri@hanmail.net    
      Principal Investigator: Kyoung-Ho Yoon, MD            
      Sub-Investigator: Seung-Mok Cho, MD            
Spain
Hospital Clinic i Provincial de Barcelona     Recruiting
      Barcelona, Spain, 08036
      Contact: Francisco Maculé, MD     +34932275400        
      Contact: Raquel Sánchez     34 65 475 62 22     raquelsc176@hotmail.com    
      Principal Investigator: Francisco Maculé, MD            
      Sub-Investigator: Juan Carlos Martinez, MD            
Hospital de La Esperanza     Recruiting
      Barcelona, Spain, 08024
      Contact: Ferran Montserrat, MD     +34932679170        
      Contact: Raquel Sánchez            
      Principal Investigator: Ferran Monserrat, MD            
      Sub-Investigator: Juan Carlos Monllau, MD            
Hospital Universitario Gregorio Maraňón     Recruiting
      Madrid, Spain, 28034
      Contact: Javier Vaquero, MD     +34915868425        
      Contact: Gema Perez     +34 616 166 114     gperezprudencio@yahoo.es    
      Principal Investigator: Javier Vaquero, MD            
      Sub-Investigator: Diego Garcia Rodriguez, MD            
Hospital La Paz     Recruiting
      Madrid, Spain
      Contact: Santiago Bello, MD     34 91 727 70 00     santibelloprats@hotmail.com    
      Contact: Pedro Pastor         pedro.pastor@meditrial.es    
      Principal Investigator: Santiago Bello, MD            
Spain, Madrid
FREMAP Centro de Prevención y Rehabilitación     Recruiting
      Majadahonda, Madrid, Spain, 28220
      Contact: Felipe López-Oliva, MD     +34916265644        
      Contact: Raul Esparza     +34 916 265 644     raul_esparza@fremap.es    
      Principal Investigator: Felipe López-Oliva, MD            
      Sub-Investigator: Manuel Leyes, MD            

Sponsors and Collaborators
BioSyntech Canada Inc.

Investigators
Principal Investigator:     William Stanish, MD     Orthopaedic and Sport Medicine - Dalhousie University    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Publications:

Responsible Party:   BioSyntech Canada Inc. ( Richard Lacombe )
Study ID Numbers:   CG-CIP01-P
First Received:   April 11, 2006
Last Updated:   April 16, 2008
ClinicalTrials.gov Identifier:   NCT00314236
Health Authority:   Canada: Health Canada; Spain: AEMPS

Keywords provided by BioSyntech Canada Inc.:
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

Study placed in the following topic categories:
Chitosan
Wounds and Injuries
Disorders of Environmental Origin
Knee Injuries
Leg Injuries
Pain

ClinicalTrials.gov processed this record on November 19, 2008




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