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

Tracking Information

First Received Date ^ICMJE

April 11, 2006

Last Updated Date

March 13, 2009

Start Date ^ICMJE

December 2005

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

degree of filling of the lesion by repair tissue at 12 months through delayed gadolinium enhanced magnetic resonance imaging of cartilage (dGEMRIC)
repair tissue quality at 12 months.

Change History

Complete list of historical versions of study NCT00314236 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

knee-related pain at 12 months
knee-related stiffness at 12 months
knee-related function at 12 months

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Knee Injuries

Intervention ^ICMJE

Device: BST-CarGel

Study Arms / Comparison Groups

Experimental: Microfracture plus BST-CarGel
Active Comparator: Microfracture alone

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2010

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada, Korea, Republic of, Spain

Administrative Information

NCT ID ^ICMJE

NCT00314236

Responsible Party

Ligia Stern, Bio Syntech Canada Inc.

Study ID Numbers ^ICMJE

CG-CIP01-P

Study Sponsor ^ICMJE

BioSyntech Canada Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

William Stanish, MD

Orthopaedic and Sport Medicine - Dalhousie University

Information Provided By

BioSyntech Canada Inc.

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP