Clinical trial NCT01246895: Follow-Up Study Evaluating The Long Term Safety and Efficacy of BST-CarGel and Microfracture Repair of the Knee
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Injuries
Keywords: Cartilage repair
Cartilage
Knee
Knee Pain
Microfracture
Arthroscopy
Bone Marrow Stimulation
Chondrogenesis
Scaffold
Chitosan
Articular Cartilage Repair
Lead sponsor: Piramal Healthcare Canada Ltd
Sponsor class: INDUSTRY
First posted: 2010-11-24
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that have been treated under either protocol CG-CIP01 or CG-CIP02

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.

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 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

Primary outcomes:
measure: Degree of Lesion Filling (%Fill) by Repair Tissue at Degree of Lesion Filling (%Fill) by Repair Tissue at 5 Years Through MRI.
timeFrame: 5 years
measure: Repair Tissue Quality (T2 MRI)
timeFrame: 5 years
Secondary outcomes:
measure: Percentage Change From Baseline for Knee-related Pain, Stiffness and Function at 5 Years (WOMAC Parts A, B, C)
timeFrame: 5 years
measure: The Number of Participants With Adverse Events Until 5 Years
timeFrame: 5 years
Other outcomes:
measure: Percentage Change in Quality of Life Assessed Using the SF-36 Questionnaire.
timeFrame: 1 and 5 years
Locations:
city: Calgary
country: Canada
facility: University of Calgary Sports Medicine Centre
state: Alberta
city: New Westminster
country: Canada
facility: Simon Fraser Orthopaedic Fund, Royal Columbian Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Joint Preservation Centre of British Columbia
state: British Columbia
city: Winnipeg
country: Canada
facility: Pan Am Clinic
state: Manitoba
city: Halifax
country: Canada
facility: Orthopaedic and Sport Medicine Clinic of Nova Scotia
state: Nova Scotia
city: Oakville
country: Canada
facility: Oakville Trafalgar Memorial Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Sports Medicine Center, Carleton University
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre, Orthopaedics Research Office
state: Ontario
city: Montreal
country: Canada
facility: Hospital Sacré-Coeur de Montréal
state: Quebec
city: Québec
country: Canada
facility: CHA-Pavillon Enfant-Jésus
state: Quebec
city: Québec
country: Canada
facility: Hôpital Charles LeMoyne, Unité d'investigation non invasive
state: Quebec
city: Majadahonda
country: Spain
facility: FREMAP Centro de Prevención y Rehabilitatión
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Gijon
country: Spain
facility: Cirugia Ortopedica y Traumatologia, Medicina del Deporte
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Orthopaedic and Sport Medicine - Dalhousie University
name: William Stanish, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shive MS, Stanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Methot S, Vehik K, Restrepo A. BST-CarGel(R) Treatment Maintains Cartilage Repair Superiority over Microfracture at 5 Years in a Multicenter Randomized Controlled Trial. Cartilage. 2015 Apr;6(2):62-72. doi: 10.1177/1947603514562064.