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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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.
Collagen of articular cartilage. Microfracture for knee chondral defects: Statistical Analysis Sample size determination for the 1-year trial was previously reported. Limited information was released by the patient except that the SAE was ongoing at the time of the 5-year follow-up period. During the 5-year follow-up period, 54 AEs were reported in 31 individual patients, 13 Results after microfracture of full-thickness chondral defects in different compartments in the kneeOsteoarthritis Cartilage.
Trial Detail – UK Clinical Trial Gateway
Open the catalog to page 9. Biotechnol Genet Eng Rev ; Please look again shortly if the information you need is not here or, if named, contact the researcher named above. Shigemasa Y, Minami S. Declaration of Conflicting Interests: The extension study protocol https: The bootstrap method was used to account for sample size differences. The response of articular cartilage to mechanical injury. Microfracture to treat full-thickness chondral defects: Safety Overall, both trial treatments were well tolerated and the safety profiles bsf considered comparable.
Patient age, 31505556 BMI, 3257 time from onset of symptoms, 3456 gender, lesion size, and location are all relevant, 58 although other procedure-based vst such as technical aspects of the surgical treatment and postoperative rehabilitation 5859 could also play critical roles. Factors predictive of outcome 5 years after matrix-induced autologous chondrocyte implantation in the tibiofemoral joint.
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.
J Orthop Surg Res. T2 mapping in the knee after microfracture at 3. Chitosan is an abundant glucosamine polysaccharide found in the exoskeleton of crustaceans and has many desirable biomaterial properties. Effects of calcified cartilage on healing of chondral defects treated with microfracture in horses.
The adverse effect of elevated body mass index on outcome after autologous chondrocyte implantation. Durability of cartilage repair—does histology matter? Chitosan chemistry and pharmaceutical perspectives. Journal List Cartilage v. Secondary and Tertiary Bt 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: Clin Orthop Relat Res.
No patient in either treatment group was discontinued from the study because of an AE, SAE, or incident. Applications of chitin and chitosan for biomaterials. Further details and illustrations in Stanish et al.
Higher positive scores indicate better results. Values represent mean change from baseline adjusted for baseline and standard errors. Composition and structure of czrgel cartilage: Author information Copyright and License information Disclaimer. Outcome Measures Primary Outcome Repair tissue structure, defined as both the quantity and quality of new tissue, was assessed as the primary outcome.
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Safety was comparable for both groups. Second, optimal MFX surgical technique was strictly obeyed in both groups. Structural characteristics of the collagen network in human normal, degraded and repair articular cartilages observed in polarized light and scanning electron microscopies.
Approximately participants with full-thickness grade III dargel IV cartilage lesions will be randomised in a 1: Data collection and blinded analyses were conducted by third parties as described herein.
The equivalent clinical improvement between groups was an expected finding for 2 predictable reasons.