Trial Comparing BST-CarGel and Microfracture in Repair of Articular Cartilage Lesions in the Knee

Knee Injuries Clinical Trial

Official title:

A Randomized, Comparative Multicenter Clinical Trial Evaluating BST-CarGel™ and Microfracture in Repair of Focal Articular Cartilage Lesions on the Femoral Condyle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314236
• Other study ID #: CG-CIP01-P
• Status: Completed
• Phase: N/A
• First received: April 11, 2006
• Last updated: December 17, 2015
• Start date: December 2005
• Est. completion date: May 2011

Study information

• Verified date: December 2015
• Source: Piramal Healthcare Canada Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaSpain: Ministry of HealthKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will investigate whether the treatment of damaged cartilage in the knee with BST-CarGel will increase the amount and quality of cartilage repair tissue when compared with microfracture alone. Furthermore, the effect of BST-CarGel in decreasing cartilage related pain and improving cartilage-related function in the knee will be assessed.

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.

This Canadian trial will be a pivotal protocol study, conducted as a randomized, controlled trial. A total of 80 subjects, 40 subjects in each of the two groups (BST-CarGel applied to a microfractured lesion or microfracture alone), will be enrolled in this study. The subjects and investigative medical staff will not be blinded to treatment due to the difference in surgical incision size. However, although the treatment will not be blinded, the primary effectiveness assessment will be blinded. The primary endpoint of this study will be cartilage repair at 12 months proved by demonstrating that BST-CarGel treatment effectively fills cartilage lesions with high quality cartilaginous tissue. The secondary endpoints will be pain, stiffness and function while other tertiary endpoints will include safety, quality-of-life (QOL), as well as macroscopic characterizations of tissue repair. The primary measure of this study will occur at 12 months, when imaging of repair tissue using magnetic resonance (MR) and associated analyses will compare tissue volume, quality and other anatomical variables. Radiographic evaluations will be blinded. Volunteer biopsies at 13 months may be obtained. Pain, stiffness, function and QOL will be assessed prior to treatment, and at 3, 6 and 12 months following treatment using self-administered validated scores (WOMAC and SF-36). In addition, subject safety will be assessed through a record of adverse events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Between 18 and 55 years of age

• Focal articular cartilage lesion on the medial femoral condyle

• Grade 3 or 4 acute (traumatic) or chronic (degenerative) lesion

• Stable knee

Exclusion Criteria:

• Multiple lesions or kissing lesions

• Clinically relevant compartment malalignment (> 5 degrees)

• Undergone ligament treatments in the affected knee within 2 years prior to trial

• Inflammatory arthropathy, such as rheumatoid arthritis, systemic lupus, or active gout

• Previous surgical cartilage treatments in the affected knee in the last 12 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Injuries

Intervention

Device:
• BST-CarGel with Microfracture
Microfracture performed with BST-CarGel added to the treated defect

Procedure:
• Microfracture without BST-CarGel
Microfracture performed without BST-CarGel added to the treated defect.

Locations

Country	Name	City	State
Canada	Sports Medicine Centre - University of Calgary	Calgary	Alberta
Canada	Hopital Charles LeMoyne	Greenfield Park	Quebec
Canada	Orthopaedic and Sport Medicine Clinic of Nova Scotia	Halifax	Nova Scotia
Canada	Hospital Sacré-Coeur de Montréal	Montreal	Quebec
Canada	New West Sports Medicine	New Westminster	British Columbia
Canada	Entralogix Clinical Group Inc.	Newmarket	Ontario
Canada	Sports Medicine Clinic - Carleton University	Ottawa	Ontario
Canada	Centre Hospitalier Affilie Universitaire de Quebec et Hôpital Valcartier	Quebec
Canada	Sunnybrook Health Sciences Centre, Div. of Orthopaedic Surgery	Toronto	Ontario
Canada	Hospital at UBC	Vancouver	British Columbia
Canada	Pan Am Clinic	Winnipeg	Manitoba
Korea, Republic of	Kyung Hee University Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona
Spain	Hospital Begona de Gijon	Gijon	Asturias
Spain	Hospital La Paz	Madrid
Spain	Hospital Universitario Gregorio Maranón	Madrid
Spain	FREMAP Centro de Prevención y Rehabilitación	Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Piramal Healthcare Canada Ltd

Countries where clinical trial is conducted

Canada,  Korea, Republic of,  Spain, 

References & Publications (4)

Chevrier A, Hoemann CD, Sun J, Buschmann MD. Chitosan-glycerol phosphate/blood implants increase cell recruitment, transient vascularization and subchondral bone remodeling in drilled cartilage defects. Osteoarthritis Cartilage. 2007 Mar;15(3):316-27. Epub 2006 Sep 26. — View Citation

Hoemann CD, Hurtig M, Rossomacha E, Sun J, Chevrier A, Shive MS, Buschmann MD. Chitosan-glycerol phosphate/blood implants improve hyaline cartilage repair in ovine microfracture defects. J Bone Joint Surg Am. 2005 Dec;87(12):2671-86. — View Citation

Hoemann CD, Sun J, McKee MD, Chevrier A, Rossomacha E, Rivard GE, Hurtig M, Buschmann MD. Chitosan-glycerol phosphate/blood implants elicit hyaline cartilage repair integrated with porous subchondral bone in microdrilled rabbit defects. Osteoarthritis Cartilage. 2007 Jan;15(1):78-89. Epub 2006 Aug 8. — View Citation

Stanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Restrepo A, Shive MS. Novel scaffold-based BST-CarGel treatment results in superior cartilage repair compared with microfracture in a randomized controlled trial. J Bone Joint Surg Am. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of Filling of the Lesion by Repair Tissue at 12 Months Through MRI.	Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the degree of lesion filling of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI scans. The MR images will be acquired using high resolution 3D cartilage imaging sequences, so-called cartilage morphology sequences.	12 months	No
Primary	Repair Cartilage T2 Relaxation Time	Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the repair tissue quality of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI T2 mapping. T2 maps are created by calculating the T2 relaxation times for repair tissue and cartilage plates for every voxel (picture element of a MRI scan containing the average signal information of a specific spatial location of the imaged body).	12 months	No
Secondary	Change From Baseline for Knee-related Pain, Stiffness and Function at 12 Months (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.	12 months	No
Secondary	Frequency of Adverse Events Between Study Groups		12 months	Yes

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