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

Primary Purpose

Knee Injuries

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
BST-CarGel with Microfracture
Microfracture without BST-CarGel
Sponsored by
Piramal Healthcare Canada Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Injuries focused on measuring Cartilage repair, Cartilage, Knee, Knee Pain, Microfracture, arthroscopy, bone marrow stimulation, Chondrogenesis, Scaffold, Chitosan, A02.165.165, A10.165.382.332, G07.574.500.325.377.625.180, A10.165.382.400, Articular Cartilage Repair

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sports Medicine Centre - University of Calgary
  • New West Sports Medicine
  • Hospital at UBC
  • Pan Am Clinic
  • Orthopaedic and Sport Medicine Clinic of Nova Scotia
  • Entralogix Clinical Group Inc.
  • Sports Medicine Clinic - Carleton University
  • Sunnybrook Health Sciences Centre, Div. of Orthopaedic Surgery
  • Hopital Charles LeMoyne
  • Hospital Sacré-Coeur de Montréal
  • Centre Hospitalier Affilie Universitaire de Quebec et Hôpital Valcartier
  • Seoul National University Hospital
  • Kyung Hee University Medical Center
  • Hospital Begona de Gijon
  • FREMAP Centro de Prevención y Rehabilitación
  • Hospital Clinic i Provincial de Barcelona
  • Hospital Universitario Gregorio Maraňón
  • Hospital La Paz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Microfracture with BST-CarGel

Microfracture without BST-CarGel

Arm Description

BST-CarGel applied to a Microfractured lesion in repair of focal articular cartilage lesions on the femoral condyle

Microfractured lesion in repair of focal articular cartilage lesions on the femoral condyle

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.
Frequency of Adverse Events Between Study Groups

Full Information

First Posted
April 11, 2006
Last Updated
December 17, 2015
Sponsor
Piramal Healthcare Canada Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00314236
Brief Title
Trial Comparing BST-CarGel and Microfracture in Repair of Articular Cartilage Lesions in the Knee
Official Title
A Randomized, Comparative Multicenter Clinical Trial Evaluating BST-CarGel™ and Microfracture in Repair of Focal Articular Cartilage Lesions on the Femoral Condyle
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Piramal Healthcare Canada Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries
Keywords
Cartilage repair, Cartilage, Knee, Knee Pain, Microfracture, arthroscopy, bone marrow stimulation, Chondrogenesis, Scaffold, Chitosan, A02.165.165, A10.165.382.332, G07.574.500.325.377.625.180, A10.165.382.400, Articular Cartilage Repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microfracture with BST-CarGel
Arm Type
Experimental
Arm Description
BST-CarGel applied to a Microfractured lesion in repair of focal articular cartilage lesions on the femoral condyle
Arm Title
Microfracture without BST-CarGel
Arm Type
Active Comparator
Arm Description
Microfractured lesion in repair of focal articular cartilage lesions on the femoral condyle
Intervention Type
Device
Intervention Name(s)
BST-CarGel with Microfracture
Intervention Description
Microfracture performed with BST-CarGel added to the treated defect
Intervention Type
Procedure
Intervention Name(s)
Microfracture without BST-CarGel
Intervention Description
Microfracture performed without BST-CarGel added to the treated defect.
Primary Outcome Measure Information:
Title
Degree of Filling of the Lesion by Repair Tissue at 12 Months Through MRI.
Description
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.
Time Frame
12 months
Title
Repair Cartilage T2 Relaxation Time
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change From Baseline for Knee-related Pain, Stiffness and Function at 12 Months (WOMAC Parts A, B, C)
Description
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.
Time Frame
12 months
Title
Frequency of Adverse Events Between Study Groups
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Stanish, MD
Organizational Affiliation
Orthopaedic and Sport Medicine - Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sports Medicine Centre - University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
Facility Name
New West Sports Medicine
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 5P5
Country
Canada
Facility Name
Hospital at UBC
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
Facility Name
Pan Am Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3E4
Country
Canada
Facility Name
Orthopaedic and Sport Medicine Clinic of Nova Scotia
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 4M2
Country
Canada
Facility Name
Entralogix Clinical Group Inc.
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
Sports Medicine Clinic - Carleton University
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1S 5B6
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre, Div. of Orthopaedic Surgery
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3N 3M5
Country
Canada
Facility Name
Hopital Charles LeMoyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Hospital Sacré-Coeur de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Centre Hospitalier Affilie Universitaire de Quebec et Hôpital Valcartier
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Kyung Hee University Medical Center
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
Hospital Begona de Gijon
City
Gijon
State/Province
Asturias
ZIP/Postal Code
33204
Country
Spain
Facility Name
FREMAP Centro de Prevención y Rehabilitación
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28220
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Gregorio Maraňón
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
16322617
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):2671-2686. doi: 10.2106/JBJS.D.02536.
Results Reference
background
PubMed Identifier
17008111
Citation
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. doi: 10.1016/j.joca.2006.08.007. Epub 2006 Sep 26.
Results Reference
background
PubMed Identifier
16895758
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. doi: 10.1016/j.joca.2006.06.015. Epub 2006 Aug 8.
Results Reference
background
PubMed Identifier
24048551
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. 2013 Sep 18;95(18):1640-50. doi: 10.2106/JBJS.L.01345.
Results Reference
result
Links:
URL
http://bst-cargel.piramal.com/
Description
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Trial Comparing BST-CarGel and Microfracture in Repair of Articular Cartilage Lesions in the Knee

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