Randomized Evaluation of BST-CarGel Versus Microfracture Alone On Recovery From Distal Femoral Cartilage Lesions (RECORD)
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|ClinicalTrials.gov Identifier: NCT02981355|
Recruitment Status : Recruiting
First Posted : December 5, 2016
Last Update Posted : August 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Traumatic; Lesion Degenerative Lesion of Articular Cartilage of Knee||Procedure: Microfracture treatment Device: BST-CarGel||Phase 4|
The current standard of treatment for cartilage lesions on the femoral condyle is microfracture, which is conducted by penetrating the subchondral bone below the lesion. This procedure creates a natural healing response as a result of the bleeding and clotting caused by the microfracture, restoring the lesion. BST-CarGel (Piramal Life Sciences, Bio-Orthopaedic Division), a liquid chitosan-containing polymer scaffolding, has been developed as an intra-articular injectable scaffold to aid in the stabilization of the blood clot created by microfracture. BST-CarGel does not interfere with the normal clotting process; however, it enables a prolonged healing time due to the increased stabilization of the clot within the lesion and the inhibition of clot retraction.
The RECORD trial is a multi-centre, randomized, controlled trial to assess the impact of the BST-CarGel scaffold and microfracture versus microfracture alone on short term clinical benefit as measured by loaded knee pain on a visual analogue scale (3-6 months), mid-long term clinical benefit as measured by the same loaded knee pain (9, 12, and 24 months) and Tegner Activity Score (TAS), International Knee Documentation Committee (IKDC), and Knee Injury and Osteoarthritis (KOOS) at 3, 6, 9, 12 and 24 months post-operatively. Approximately 158 participants with full-thickness grade III and IV cartilage lesions will be randomised in a 1:1 ratio to receive one of the two treatments during an arthroscopic procedure and will be followed for up to 24 months to collect outcomes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||158 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Evaluation of BST-CarGel Versus Microfracture Alone On Recovery From Distal Femoral Cartilage Lesions|
|Actual Study Start Date :||July 26, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Microfracture treatment
Microfracture surgery of the femoral condyle
Procedure: Microfracture treatment
Microfracture is performed by penetrating the subchondral bone beneath the cartilage lesion inducing a bleeding response.
Experimental: BST-CarGel plus microfracture treatment
BST-CarGel combined with fresh, autologous whole blood and applied to the lesion on the femoral condyle with a syringe following an arthroscopic microfracture surgery.
Procedure: Microfracture treatment
Microfracture is performed by penetrating the subchondral bone beneath the cartilage lesion inducing a bleeding response.Device: BST-CarGel
BST-CarGel is combined with fresh, autologous whole blood and applied to the lesion on the femoral condyle with a syringe following microfracture arthroscopic surgery.
- Change in loaded knee pain visual analogue scale (VAS) [ Time Frame: Baseline to 24 months post-surgery ]Used to demonstrate patient clinical improvement. The VAS is one of the most commonly used measures of pain intensity, where the patient rates their pain on a scale from 0 to 10 (0=no pain; 10=maximum pain possible).
- Change in knee function measured by the TAS questionnaire [ Time Frame: Baseline to 24 months post-surgery ]The TAS is a validated patient-administered questionnaire for use in multiple knee injuries and consists of a numerical scale ranging from 0 to 10 to indicate the ability to perform specific activities.
- Change in knee function measured by the IKDC questionnaire [ Time Frame: Baseline to 24 months post-surgery ]The IKDC measures the progress in symptoms, function, and sports activities caused by knee impairment after a treatment has been performed. It can be used with reliability and validity in patients with a range of knee conditions.
- Change in knee function measured by the KOOS questionnaire [ Time Frame: Baseline to 24 months post-surgery ]The KOOS is a measure of a patient's perceived knee pain and function, as well as associated problems with their knee status. It contains 42 items that are all recorded on a five-point Likert Scale by the patient.
- Repair tissue quantity and quality [ Time Frame: 12 and 24 months post-surgery ]Measured by MOCART II Score complemented by T2 MRI mapping. The MOCART II Score will be completed by two independent, blinded, well-trained radiologist readers.
- Adverse events related to treatment [ Time Frame: surgical visit, 2 weeks, 6 weeks, 3 months, 6 months, 9 months,12 months and 24 months post-surgery ]
- Quality of life [ Time Frame: 3,6,9,12 and 24 months post-surgery ]Measured by the EQ-5D-3L health questionnaire. The EQ-5D-3L health questionnaire is a standardized instrument utilized as a measure of health outcomes and can be applied to an extensive range of health conditions.
- Economic evaluation [ Time Frame: surgical visit, 2 weeks, 6 weeks, 3 months, 6 months, 9 months,12 months and 24 months post-surgery ]Measured by a study-specific Resource Utilization Questionnaire which will be used to determine the costs associated with the use of the BST-CarGel scaffold treatment.
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): NCT02981355
|Contact: David A Pogorzelski, MScemail@example.com|
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|Study Chair:||Jean-Pierre Desmarais||Piramal Healthcare Canada Ltd|