Follow-Up Study Comparing BST-CarGel and Microfracture in Repair of Articular Cartilage Lesions in the Knee

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Piramal Healthcare Canada Ltd
ClinicalTrials.gov Identifier:
NCT01246895
First received: November 22, 2010
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

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
Focal Articular Cartilage Lesions on the Femoral Condyle

Study Type: Observational
Study Design: 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)

Further study details as provided by Piramal Healthcare Canada Ltd:

Primary Outcome Measures:
  • Degree of filling of the lesion by repair tissue at 60 months through Magnetic Resonance Imaging of cartilage [ Time Frame: 60 months ] [ Designated as safety issue: No ]
    Degree of lesion filling and quality of tissue repair at 60 months through quantitative Magnetic Resonance Imaging of cartilage


Secondary Outcome Measures:
  • Knee-related pain, stiffness and function at 60 months (WOMAC parts A, B, C) [ Time Frame: 60 months ] [ Designated as safety issue: No ]
    Long-term safety and efficacy of treatment on knee pain, stiffness, functional ability, general health status and quality of life at 60 months ( WOMAC, parts A,B,C)


Other Outcome Measures:
  • Long-term safety at 60 months through the frequency and severity of Adverse Events [ Time Frame: 60 months ] [ Designated as safety issue: No ]
    Evaluate the long-term safety at 60 months through the frequency and severity of Adverse Events


Estimated Enrollment: 80
Study Start Date: December 2010
Estimated Study Completion Date: March 2014
Groups/Cohorts
Expiremental
BST CarGel+ Microfracture
Control
Microfracture alone

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)
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 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
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
  More Information

No publications provided

Responsible Party: Piramal Healthcare Canada Ltd
ClinicalTrials.gov Identifier: NCT01246895     History of Changes
Other Study ID Numbers: CG-CIP04-P
Study First Received: November 22, 2010
Last Updated: September 21, 2012
Health Authority: Canada: Health Canada
Spain: Agencia Española del Medicamento y Productos Sanitarios (AEMPS)

Keywords provided by Piramal Healthcare Canada Ltd:
Cartilage repair
Cartilage
Knee
Knee Injuries
Knee Pain
Microfracture
Bone Marrow Stimulation
Arthroscopy

ClinicalTrials.gov processed this record on August 28, 2014