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

December 17, 2015 updated by: Piramal Healthcare Canada Ltd

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1J 1Z4
        • Centre Hospitalier Affilie Universitaire de Quebec et Hôpital Valcartier
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • Sports Medicine Centre - University of Calgary
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 5P5
        • New West Sports Medicine
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • Hospital at UBC
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3E4
        • Pan Am Clinic
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 4M2
        • Orthopaedic and Sport Medicine Clinic of Nova Scotia
    • Ontario
      • Newmarket, Ontario, Canada, V6T 2B5
        • Entralogix Clinical Group Inc.
      • Ottawa, Ontario, Canada, K1S 5B6
        • Sports Medicine Clinic - Carleton University
      • Toronto, Ontario, Canada, M3N 3M5
        • Sunnybrook Health Sciences Centre, Div. of Orthopaedic Surgery
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Hopital Charles LeMoyne
      • Montreal, Quebec, Canada, H4J 1C5
        • Hospital Sacre-Coeur de Montreal
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 130-702
        • Kyung Hee University Medical Center
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic i Provincial de Barcelona
      • Madrid, Spain
        • Hospital La Paz
      • Madrid, Spain, 28034
        • Hospital Universitario Gregorio Marañon
    • Asturias
      • Gijon, Asturias, Spain, 33204
        • Hospital Begona de Gijon
    • Madrid
      • Majadahonda, Madrid, Spain, 28220
        • FREMAP Centro de Prevención y Rehabilitación

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microfracture with BST-CarGel
BST-CarGel applied to a Microfractured lesion in repair of focal articular cartilage lesions on the femoral condyle
Device: BST-CarGel with Microfracture
Microfracture performed with BST-CarGel added to the treated defect
Active Comparator: Microfracture without BST-CarGel
Microfractured lesion in repair of focal articular cartilage lesions on the femoral condyle
Procedure: Microfracture without BST-CarGel
Microfracture performed without BST-CarGel added to the treated defect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of Filling of the Lesion by Repair Tissue at 12 Months Through MRI.
Time Frame: 12 months
Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the degree of lesion filling of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI scans. The MR images will be acquired using high resolution 3D cartilage imaging sequences, so-called cartilage morphology sequences.
12 months
Repair Cartilage T2 Relaxation Time
Time Frame: 12 months
Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the repair tissue quality of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI T2 mapping. T2 maps are created by calculating the T2 relaxation times for repair tissue and cartilage plates for every voxel (picture element of a MRI scan containing the average signal information of a specific spatial location of the imaged body).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline for Knee-related Pain, Stiffness and Function at 12 Months (WOMAC Parts A, B, C)
Time Frame: 12 months
The three sub-scales: 1) Pain, 2.) stiffness and 3.) function scores ranged from 0-10. Pain had 5 items and stiffness had 2 items, and function had 17 items. The total score for pain ranged from 0 no pain to 50 worst pain. The total score for stiffness ranged from 0 no stiffness to 20 worst stiffness. The total score for function raged from 0 no function to 170 worst function.
12 months
Frequency of Adverse Events Between Study Groups
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Piramal Healthcare Canada Ltd

Investigators

  • Principal Investigator: William Stanish, MD, Orthopaedic and Sport Medicine - Dalhousie University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

April 11, 2006

First Submitted That Met QC Criteria

April 12, 2006

First Posted (Estimate)

April 13, 2006

Study Record Updates

Last Update Posted (Estimate)

December 18, 2015

Last Update Submitted That Met QC Criteria

December 17, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CG-CIP01-P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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