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Follow-Up Study Evaluating The Long Term Safety and Efficacy of BST-CarGel and Microfracture Repair of the Knee

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ClinicalTrials.gov Identifier: NCT01246895
Recruitment Status : Completed
First Posted : November 24, 2010
Results First Posted : January 24, 2018
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Piramal Healthcare Canada Ltd

Brief Summary:
This follow-up study will evaluate the effects of BST-CarGel® application to a microfractured lesion (investigational) and microfracture alone (control) for up to 5 years from treatment in subjects, treated under Protocols CG-CIP01-P and CG-CIP02-P, and will serve as a post approval study for these Protocols, in support of a commercial application. The lesions treated under Protocols CG-CIP01-P and CG-CIP02-P were focal lesions of articular cartilage, grade 3 or 4 (either ICRS or Outerbridge classification) on the medial and lateral femoral condyles of the knee, and were classified as either acute or chronic.

Condition or disease Intervention/treatment
Knee Injuries Device: Microfracture with BST-CarGel Device: Microfracture without BST-CarGel

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.

Clinical data regarding the long-term durability of repair tissue resulting from cartilage repair techniques such as microfracture, autologous chondrocyte implantation or mosaicplasty is lacking. Only two studies, one comparative and one uncontrolled, have examined long-term repair outcomes (over 4 years). These studies reinforced the concept that further studies are needed to identify a technique or product that will lead to long-term clinical benefit through improved cartilage repair efficacy.

BST-CarGel® is a medical device derived from chitosan applied to a microfractured lesion and has been shown to promote the quantity and quality of cartilage repair tissue in animals. The efficacy and safety of BST-CarGel® is currently being evaluated in humans as compared to the standard of care treatment, microfracture, in a 12 month international study in Canada, Europe and Korea under Protocols CG-CIP01-P and CG-CIP02-P. When these protocols were designed and carried out, the BST-CarGel® technology belonged to BioSyntech Canada Inc. Afterwards, the technology was acquired by Piramal Healthcare (Canada) Ltd. which is now the owner of the technology and the sponsor for this Extension Study CG-C1P04.

This follow-up study will evaluate the long-term effects (5 yrs) of BST-CarGel® + microfracture and microfracture alone in subjects treated in the pivotal and sub-studies.

All eligible subjects (maximum 80) who were treated under Protocols CG-CIP01-P and CG-CIP02-P and completed the required 12 month follow-up period will be asked to participate in this follow-up study.

The stratification from Protocols CG-CIP01-P and CG-CIP02-P (investigational site and lesion type) will be retained for the purposes of the follow-up study, and all third parties such as the MRI central reading facility will remain blinded to the treatment received under Protocols CG-CIP01-P and CG-CIP02-P.

Comparisons between the two treatment groups will be performed.

The following assessments will be done annually at years 3 and/or 4 and 5 post -treatment under Protocols CG-CIP01-P and CG-CIP02-P in subjects treated with BST-CarGel + microfracture or microfracture alone:

  1. Analyses of tissue repair will be carried out based on the degree of lesion filling and quality of repair tissue using MRI
  2. The general health status of subjects will be captured in the case report form (CRF) and will include the subject's overall health status, treated knee status, adverse events (AEs) and concomitant medications.
  3. The assessment of the subject's knee pain, stiffness, functional ability and quality of life through self-assessment questionnaires (Western Ontario and McMaster Universities osteoarthritis index (WOMAC) and short-form-36 (SF-36v2)

Study Type : Observational
Actual Enrollment : 67 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Follow-up Study Evaluating The Long-Term Safety and Efficacy of BST-CarGel® and Microfracture In Repair of Focal Articular Cartilage Lesions on The Femoral Condyle (Extension Study of Protocols CG-CIP01-P & CG-CIP02-P)
Study Start Date : March 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Experimental
Microfracture with BST-CarGel
Device: Microfracture with BST-CarGel
Control
Microfracture without BST-CarGel
Device: Microfracture without BST-CarGel



Primary Outcome Measures :
  1. Degree of Lesion Filling (%Fill) by Repair Tissue at Degree of Lesion Filling (%Fill) by Repair Tissue at 5 Years Through MRI. [ Time Frame: 5 years ]
    Degree of lesion filling (repair tissue volume) as measured by quantitative MRI at 5 Years post-treatment compared to the debrided lesion 1-month post-treatment (baseline).

  2. Repair Tissue Quality (T2 MRI) [ Time Frame: 5 years ]
    Tissue quality of the repair tissue as measured by T2 MRI as an index for collagen-based structure.


Secondary Outcome Measures :
  1. Percentage Change From Baseline for Knee-related Pain, Stiffness and Function at 5 Years (WOMAC Parts A, B, C) [ Time Frame: 5 years ]
    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. A higher score indicates a better health state improvement.

  2. The Number of Participants With Adverse Events Until 5 Years [ Time Frame: 5 years ]
    Safety was assessed by recording the number of participants with Adverse Events (AEs) and their severity from the time of ICF signing up to 5 years post-treatment.


Other Outcome Measures:
  1. Percentage Change in Quality of Life Assessed Using the SF-36 Questionnaire. [ Time Frame: 1 and 5 years ]
    SF-36 v2 includes 2 aggregate measures—Physical and Mental components—derived from 8 subscales. Least squares means are adjusted for baseline. Higher positive scores indicate better results. Scoring ranges from 0 to 100%.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients that have been treated under either protocol CG-CIP01 or CG-CIP02
Criteria

Inclusion Criteria:

  • The subject was treated under Protocol CG-CIP01 or CG-CIP02 and completed 12 month follow-up period
  • The subject has understood and signed a Research Ethics Board(REB) approved Informed Consent Form (ICF)

Exclusion Criteria:

  • The subject was not treated under Protocol CG-CIP01-P or CG-CIP02-P
  • The subject did not complete 12 month follow-up period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246895


Locations
Canada, Alberta
University of Calgary Sports Medicine Centre
Calgary, Alberta, Canada, T2N 1N4
Canada, British Columbia
Simon Fraser Orthopaedic Fund, Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Joint Preservation Centre of British Columbia
Vancouver, British Columbia, Canada, V6T 2B5
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
Oakville Trafalgar Memorial Hospital
Oakville, Ontario, Canada, L6J 3L7
Sports Medicine Center, Carleton University
Ottawa, Ontario, Canada, K1S 5B6
Sunnybrook Health Sciences Centre, Orthopaedics Research Office
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Hospital Sacré-Coeur de Montréal
Montreal, Quebec, Canada, H4J 1C5
CHA-Pavillon Enfant-Jésus
Québec, Quebec, Canada, G1J 1Z4
Hôpital Charles LeMoyne, Unité d'investigation non invasive
Québec, Quebec, Canada, J4V 2H1
Spain
FREMAP Centro de Prevención y Rehabilitatión
Majadahonda, Madrid, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Cirugia Ortopedica y Traumatologia, Medicina del Deporte
Gijon, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Hospital Universitario La Paz
Madrid, Spain
Sponsors and Collaborators
Piramal Healthcare Canada Ltd
Investigators
Principal Investigator: William Stanish, M.D Orthopaedic and Sport Medicine - Dalhousie University

Additional Information:
Publications of Results:
Responsible Party: Piramal Healthcare Canada Ltd
ClinicalTrials.gov Identifier: NCT01246895     History of Changes
Other Study ID Numbers: CG-CIP04-P
First Posted: November 24, 2010    Key Record Dates
Results First Posted: January 24, 2018
Last Update Posted: January 24, 2018
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not planned

Keywords provided by Piramal Healthcare Canada Ltd:
Cartilage repair
Cartilage
Knee
Knee Pain
Microfracture
Arthroscopy
Bone Marrow Stimulation
Chondrogenesis
Scaffold
Chitosan
Articular Cartilage Repair

Additional relevant MeSH terms:
Knee Injuries
Fractures, Stress
Leg Injuries
Wounds and Injuries
Fractures, Bone