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
|Condition or disease||Intervention/treatment||Phase|
|Knee Injuries||Device: BST-CarGel with Microfracture Procedure: Microfracture without BST-CarGel||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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).
- 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.
- Frequency of Adverse Events Between Study Groups [ Time Frame: 12 months ]
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
|Principal Investigator:||William Stanish, MD||Orthopaedic and Sport Medicine - Dalhousie University|