Blinded MRI analysis demonstrated that BST-CarGel®-treated patients showed a significantly greater treatment effect for lesion filling (P = ) over 5 years. BST-CarGel is an advanced bioscaffold technology for enhancing cartilage regeneration. BST-CarGel was developed to stabilize the blood clot in the cartilage lesion by dispersing a soluble and adhesive polymer scaffold containing chitosan.
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You are sending them the link for the trial open on this page. Shive 1 Piramal Healthcare Canada Ltd.
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By subscribing to updates on this trial we can notify you when this trial changes to a different status. J Bone Joint Surg Br ; This multi-centre randomized, controlled trial will assess the impact of BST-CarGel caegel with microfracture versus microfracture alone on short and long term clinical benefit in patients with cartilage lesions of the femoral condyle requiring operative management. Study of the collagen structure cagel the superficial zone and physiological state of articular cartilage using a 3D confocal imaging technique.
This article has been cited by other articles in PMC. Clearly, more and longer cartel are required both with structural tools and patient-reported clinical measures that are specific enough to detect improvements following cartilage repair before the relationship between clinical and structural outcomes will emerge.
Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data. T2 mapping in the knee after microfracture at 3. Open the catalog to page 8.
Please select which trial status you would like to be notified about. The extension study suffered patient loss to follow-up at all planned time points due to several factors, including extremely protracted enrolment periods for both the initial 12 month trial and the extension study, compounded by financial bankruptcy of the original trial sponsor BioSyntech Canada Inc.
Magnetic resonance observation of cartilage repair tissue MOCART for the evaluation of autologous chondrocyte transplantation: Repair tissue quantity and quality; Up to 24 months post-surgery; Adverse events related to treatment; Up to 24 months post-surgery; Economic evaluation; surgical visit, 2 weeks, 6 weeks, 3 months, 6 months, 9 months,12 months and 24 months post-surgery.
The current standard of treatment for cartilage lesions on the femoral condyle is microfracture, which cartel conducted by penetrating the subchondral bone bsst the lesion.
None of the characteristics were found to be significant covariates leading to bias during sensitivity analyses, despite reports that clinical outcomes after microfracture are age dependent.
BST-CarGel ® – Smith & Nephew – PDF Catalogs | Technical Documentation
One 1 serious AE SAE was reported by 1 subject in the MFX group, which was moderate in severity and not related in any way to the study treatment or index knee but required surgery and radiotherapy. The natural history of cartilage defects in people with cwrgel osteoarthritis. Furthermore, repair tissue structure represents a reliable clinical trial endpoint since hyaline cartilage has an exquisite structure characterized by hallmark features, including collagen content and zonal organization, glycosaminoglycan, and cell population, 69 which can be easily discriminated by highly accurate quantitative measures sensitive to early changes in cartilage structure under reasonable clinical trial time frames.
Safety was comparable for both groups. Introduction The search for a solution to problematic articular cartilage lesions continues despite decades of orthopedic experience in the knee.
T2 relaxation reveals spatial collagen architecture in articular cartilage: P values of less than 0. None of the current repair procedures, which include bone marrow cafgel, cultured cell-based therapies, and grafting, have been studied sufficiently, acrgel in the mid to long term yearsto fully understand which factors dictate longer term outcomes for this troublesome pathology.
The Online Medical Device Exhibition. Matrix-applied characterized autologous cultured chondrocytes versus microfracture: Support Center Support Center.
All blinded scans were sent to imaging core labs for centralized scan quality review and storage VirtualScopics, Rochester, NY and blinded quantitative analysis Qmetrics Technologies, Rochester, NY using validated techniques. Screening and enrollment for the initial 1-year trial took place from May to Januaryand 1-year follow-up was concluded in February Open in a separate window.
No patient in either treatment group was discontinued from the study because of an AE, SAE, or incident. Characterized chondrocyte implantation results in better structural repair when treating symptomatic cartilage defects of the knee in a randomized controlled trial versus microfracture.
BST-CarGel Piramal Life Sciences, Bio-Orthopaedic Divisiona 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. Design The international randomized controlled trial enrolled 80 patients, aged 18 to 55 years, with grade III caregl IV focal lesions on the femoral dargel. Safety was assessed through recording of all adverse events AEs up to 5 years posttreatment.
Clinical efficacy of the microfracture technique for articular cartilage repair in the knee: BST-CarGel does not interfere with the normal bxt 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.