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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.
Study NCT00314236.   Last updated on December 10, 2008.
Information provided by BioSyntech Canada Inc.
This Tabular View shows the required WHO registration data elements as marked by

Trial Comparing BST-CarGel and Microfracture in Repair of Articular Cartilage Lesions in the Knee
A Randomized, Comparative Multicenter Clinical Trial Evaluating BST-CarGel™ and Microfracture in Repair of Focal Articular Cartilage Lesions on the Femoral Condyle

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.

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.

Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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 ]
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 ]
Knee Injuries
Device: BST-CarGel
16322617,   17008111,   16895758
Related Info This link exits the ClinicalTrials.gov site
 
Recruiting
80
December 2005
December 2008

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
Both
18 Years to 55 Years
No
Contact: Ligia Stern, PhD 450-686-2437 ext 303 ligia.stern@biosyntech.com
Contact: Melissa Valcourt, Bs.C 450-686-2437 ext 247 melissa.valcourt@biosyntech.com
Canada,   Korea, Republic of,   Spain
 
NCT00314236
CG-CIP01-P
BioSyntech Canada Inc.
Principal Investigator: William Stanish, MD Orthopaedic and Sport Medicine - Dalhousie University
BioSyntech Canada Inc.
December 2008
April 11, 2006
December 10, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.