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

Knee Injuries Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01246895
• Other study ID #: CG-CIP04-P
• Status: Completed
• Phase: N/A
• First received: November 22, 2010
• Last updated: June 6, 2017
• Start date: March 2011
• Est. completion date: March 2014

Study information

• Verified date: November 2016
• Source: Piramal Healthcare Canada Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Stress
• Knee Injuries

Intervention

Device:
• Microfracture with BST-CarGel

• Microfracture without BST-CarGel

Locations

Country	Name	City	State
Canada	University of Calgary Sports Medicine Centre	Calgary	Alberta
Canada	Orthopaedic and Sport Medicine Clinic of Nova Scotia	Halifax	Nova Scotia
Canada	Hospital Sacré-Coeur de Montréal	Montreal	Quebec
Canada	Simon Fraser Orthopaedic Fund, Royal Columbian Hospital	New Westminster	British Columbia
Canada	Oakville Trafalgar Memorial Hospital	Oakville	Ontario
Canada	Sports Medicine Center, Carleton University	Ottawa	Ontario
Canada	CHA-Pavillon Enfant-Jésus	Québec	Quebec
Canada	Hôpital Charles LeMoyne, Unité d'investigation non invasive	Québec	Quebec
Canada	Sunnybrook Health Sciences Centre, Orthopaedics Research Office	Toronto	Ontario
Canada	Joint Preservation Centre of British Columbia	Vancouver	British Columbia
Canada	Pan Am Clinic	Winnipeg	Manitoba
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona
Spain	Cirugia Ortopedica y Traumatologia, Medicina del Deporte	Gijon
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	FREMAP Centro de Prevención y Rehabilitatión	Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Piramal Healthcare Canada Ltd

Countries where clinical trial is conducted

Canada,  Spain, 

References & Publications (1)

Shive MS, Stanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Méthot S, Vehik K, Restrepo A. BST-CarGel® Treatment Maintains Cartilage Repair Superiority over Microfracture at 5 Years in a Multicenter Randomized Controlled Trial. Cartilag — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage Change in Quality of Life Assessed Using the SF-36 Questionnaire.	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%.	1 and 5 years
Primary	Degree of Lesion Filling (%Fill) by Repair Tissue at Degree of Lesion Filling (%Fill) by Repair Tissue at 5 Years Through MRI.	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).	5 years
Primary	Repair Tissue Quality (T2 MRI)	Tissue quality of the repair tissue as measured by T2 MRI as an index for collagen-based structure.	5 years
Secondary	Percentage Change From Baseline for Knee-related Pain, Stiffness and Function at 5 Years (WOMAC Parts A, B, C)	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.	5 years
Secondary	The Number of Participants With Adverse Events Until 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.	5 years

External Links

•   Healthcare professionals please follow here - http://bst-cargel.piramal.com/content/medical-professional