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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Caryel Surg Sports Traumatol Arthrosc. Secondary and Tertiary Outcomes Clinical benefit was evaluated as a secondary outcome at initiation, 2, 3, 4, and 5 years posttreatment using the WOMAC questionnaire consisting of 3 subscales: Scores have maximum value of 50 for Pain, 20 for Stiffness, and for Function. T2 MRI of repair cartilage reflects both tissue quality and quantity.
The response of articular cartilage to mechanical injury.
Trial Detail – UK Clinical Trial Gateway
Microfracture to caregl full-thickness chondral defects: T2 or transverse relaxation time is well known to be sensitive to, and highly dependent on, the extracellular cartilage matrix and particularly the collagen network structure, orientation, as well as macromolecular concentration, and tissue hydration.
P values of less than 0. Check availability of results on the Clinicaltrials. Values represent mean change from baseline adjusted for baseline and standard errors.
The equivalent clinical improvement between groups was an expected finding for 2 predictable reasons. Approximately participants with full-thickness grade III and IV cartilage lesions will be randomised in a 1: Characterized chondrocyte implantation results in better structural repair when treating symptomatic cartilage defects of the knee in carbel randomized controlled trial versus microfracture.
Safety was comparable for both groups. The initial 1-year trial 26 enrolled 80 patients at 26 clinical sites. Prospective clinical study of autologous chondrocyte cargell and correlation with MRI at three and 12 months. An analysis of the quality of cartilage repair studies. Baseline demographic characteristics of the 80 patients were similar in the two treatment groups, including age, race, gender, BMI, smoking habits, and activity levels.
This interpretation for T2 MRI and its relationship to collagen organization is substantiated by a previous statistical correlation between T2 and polarized light microscopy scoring of 38 repair tissue biopsies retrieved at 1 year posttreatment in this same study.
Lower negative scores indicate better results. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial.
BST-CarGel ® – Smith & Nephew – PDF Catalogs | Technical Documentation
Steps can be done by a non-sterile nurse while the lesion xargel being surgically prepared. Thank you for helping us grow and improving medical research! T2 mapping in the knee after microfracture at 3. This article has been cited by other articles in PMC. This information is designed to help you decide whether this trial is of interest. 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.
The microfracture technique for the treatment of articular cartilage lesions in ccargel knee.
Hambly K, Griva K. Structural characteristics of the collagen network in human normal, degraded and repair articular cartilages observed in bbst light and scanning electron microscopies. Cargell equivalent clinical improvements found in this trial add to accumulating evidence that when performed properly, 9 microfracture can effectively improve clinical pain and function for the mid- to long-term despite the widely purported clinical outcome expectancy of 2 to 3 years linked to a mechanically deficient fibrocartilaginous repair tissue and excessive intralesional bony overgrowth.
Patient profiling in cartilage regeneration: Findings at five years. Limited information was released by the patient except that the SAE was ongoing at the time of the 5-year follow-up period. 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 monthsmid-long term clinical benefit as measured by the same loaded knee pain single leg squat 9, 12, and 24 months and Tegner Activity Score TASInternational Knee Documentation Committee IKDCand Knee Injury and Osteoarthritis KOOS at 3, 6, 9, 12 and 24 months post-operatively.
Factors predictive of outcome 5 years after matrix-induced autologous chondrocyte implantation in the tibiofemoral joint.
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carge, During the 5-year follow-up period, 54 AEs were reported in 31 individual patients, 13 Support Center Support Center. Acts as a scaffold to physically stabilize the blood clot in the cartilage lesion.
Novel scaffold-based BST-CarGel treatment results in superior cartilage repair compared with microfracture in a randomized controlled trial. All reported P values are 2-sided.
Patients were randomized 1: Related Searches Intramedullary nail Electrosurgical device Interference screw Bone support Acetabular prosthesis Linear stapler Arthrodesis plate Femoral prosthesis Tonsillectomy electrode Tibia compression plate Medical balloon catheter Wound therapy unit Cemented knee prosthesis Femoral head prosthetic Adenoidectomy electrode Anterolateral compression plate Dilatation catheter Arthrodesis screw Unicompartmental knee prosthesis Knee prosthetic.
Several studies have reported relationships between structural assessments and long-term clinical outcomes, but these studies suffer from small sample sizes, statistical rigor, and subjective scoring of both the structural and the clinical components. Chitosan is an abundant glucosamine polysaccharide found in the exoskeleton of crustaceans and has many desirable biomaterial properties.