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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00314236
Recruitment Status : Completed
First Posted : April 13, 2006
Results First Posted : December 18, 2015
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
Piramal Healthcare Canada Ltd

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.

Condition or disease Intervention/treatment Phase
Knee Injuries Device: BST-CarGel with Microfracture Procedure: Microfracture without BST-CarGel Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2005
Actual Primary Completion Date : February 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Microfracture with BST-CarGel
BST-CarGel applied to a Microfractured lesion in repair of focal articular cartilage lesions on the femoral condyle
Device: BST-CarGel with Microfracture
Microfracture performed with BST-CarGel added to the treated defect

Active Comparator: Microfracture without BST-CarGel
Microfractured lesion in repair of focal articular cartilage lesions on the femoral condyle
Procedure: Microfracture without BST-CarGel
Microfracture performed without BST-CarGel added to the treated defect.




Primary Outcome Measures :
  1. Degree of Filling of the Lesion by Repair Tissue at 12 Months Through MRI. [ Time Frame: 12 months ]
    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.

  2. Repair Cartilage T2 Relaxation Time [ Time Frame: 12 months ]
    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 :
  1. Change From Baseline for Knee-related Pain, Stiffness and Function at 12 Months (WOMAC Parts A, B, C) [ Time Frame: 12 months ]
    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.

  2. Frequency of Adverse Events Between Study Groups [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314236


Locations
Show Show 18 study locations
Sponsors and Collaborators
Piramal Healthcare Canada Ltd
Investigators
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Principal Investigator: William Stanish, MD Orthopaedic and Sport Medicine - Dalhousie University

Publications of Results:
Other Publications:
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Responsible Party: Piramal Healthcare Canada Ltd
ClinicalTrials.gov Identifier: NCT00314236    
Other Study ID Numbers: CG-CIP01-P
First Posted: April 13, 2006    Key Record Dates
Results First Posted: December 18, 2015
Last Update Posted: December 18, 2015
Last Verified: December 2015
Keywords provided by Piramal Healthcare Canada Ltd:
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
Additional relevant MeSH terms:
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Knee Injuries
Fractures, Stress
Leg Injuries
Wounds and Injuries
Fractures, Bone