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

NCT01246895 | Completed Results

• 1 other identifier: CG-CIP04-P
• Study Type: observational
• Target: 67
• Locations: 2 countries
• Sites: 16

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.

Conditions

Knee Injuries

Keywords

Cartilage repair; Cartilage; Knee; Knee Pain; Microfracture; Arthroscopy; Bone Marrow Stimulation; Chondrogenesis; Scaffold; Chitosan; Articular Cartilage Repair

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Percentage Change From Baseline for Knee-related Pain, Stiffness and Function at 5 Years (WOMAC Parts A, B, C)

  5 years

• The Number of Participants With Adverse Events Until 5 Years

  5 years

Other Outcomes (1)

• Percentage Change in Quality of Life Assessed Using the SF-36 Questionnaire.

  1 and 5 years

Study Arms (2)

Experimental

Microfracture with BST-CarGel

Device: Microfracture with BST-CarGel

Control

Microfracture without BST-CarGel

Device: Microfracture without BST-CarGel

Interventions

Microfracture with BST-CarGel DEVICE

Experimental

Microfracture without BST-CarGel DEVICE

Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients that have been treated under either protocol CG-CIP01 or CG-CIP02

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Piramal Healthcare Canada Ltd: lead

Study Sites (16)

University of Calgary Sports Medicine Centre

Calgary, Alberta, T2N 1N4, Canada

Location

Simon Fraser Orthopaedic Fund, Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Joint Preservation Centre of British Columbia

Vancouver, British Columbia, V6T 2B5, Canada

Location

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

Location

Orthopaedic and Sport Medicine Clinic of Nova Scotia

Halifax, Nova Scotia, B3H 4M2, Canada

Location

Oakville Trafalgar Memorial Hospital

Oakville, Ontario, L6J 3L7, Canada

Location

Sports Medicine Center, Carleton University

Ottawa, Ontario, K1S 5B6, Canada

Location

Sunnybrook Health Sciences Centre, Orthopaedics Research Office

Toronto, Ontario, M4N 3M5, Canada

Location

Hospital Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

CHA-Pavillon Enfant-Jésus

Québec, Quebec, G1J 1Z4, Canada

Location

Hôpital Charles LeMoyne, Unité d'investigation non invasive

Québec, Quebec, J4V 2H1, Canada

Location

FREMAP Centro de Prevención y Rehabilitatión

Majadahonda, Madrid, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Cirugia Ortopedica y Traumatologia, Medicina del Deporte

Gijón, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Related Publications (1)

• 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.

  PMID: 26069709 RESULT

MeSH Terms

Conditions

Knee Injuries; Fractures, Stress

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Fractures, Bone

Limitations and Caveats

Since the sample size was not predetermined, the statistical methods were used in a conditional fashion such that those that were determined to be invalid or inappropriate upon data review were discarded or replaced by more appropriate analyses.

Results Point of Contact

• Title: David Castelo, Clinical Research Manager
• Organization: Piramal Healthcare (Canada) Limited - Bio-Orthopaedics Division

david.castelo@piramal.com

450-686-2437

Study Officials

• William Stanish, M.D

  Orthopaedic and Sport Medicine - Dalhousie University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 24, 2010
• Study Start: March 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: January 24, 2018
• Results First Posted: January 24, 2018

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5); CA (11)