This multi-centre randomized, controlled trial will assess the impact of BST-CarGel scaffold with microfracture versus microfracture alone on short and long term clinical benefit in patients with cartilage lesions of the femoral condyle requiring operative management.
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 (single leg squat) on a visual analogue scale (3-6 months), mid-long term clinical benefit as measured by the same loaded knee pain (single leg squat) (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
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
5
Microfracture is performed by penetrating the subchondral bone beneath the cartilage lesion inducing a bleeding response.
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.
Calvary Wakefield Hospital
Adelaide, Australia
Murdoch Orthopaedic Clinic
Murdoch, Australia
Banff Sport Medicine
Banff, Canada
Change in loaded knee pain (single leg squat) visual analogue scale (VAS)
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).
Time frame: Baseline to 24 months post-surgery
Change in knee function measured by the TAS questionnaire
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.
Time frame: Baseline to 24 months post-surgery
Change in knee function measured by the IKDC questionnaire
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.
Time frame: Baseline to 24 months post-surgery
Change in knee function measured by the KOOS questionnaire
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.
Time frame: Baseline to 24 months post-surgery
Repair tissue quantity and quality
Measured by MOCART Score and percentage lesion fill. The MOCART Score will be completed by two independent, blinded, well-trained radiologist readers.
Time frame: Up to 24 months post-surgery
Adverse events related to treatment
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Fowler Kennedy Sport Medicine Clinic
London, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Canada
Hopital de La Croix-Rousse
Lyon, France
CHRU Nancy - Hospital Central
Nancy, France
University Medical Centre Regensburg
Regensburg, Germany
Hospital Universitari del Mar
Barcelona, Spain
Hospital Quironsalud Barcelona
Barcelona, Spain
...and 5 more locations
Time frame: Up to 24 months post-surgery
Economic evaluation
Measured by study-specific Resource Utilization Questionnaires which will be used to determine the costs associated with the use of the BST-CarGel scaffold treatment.
Time frame: surgical visit, 2 weeks, 6 weeks, 3 months, 6 months, 9 months,12 months and 24 months post-surgery