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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Sample size determination for the 1-year trial was previously reported. Correlation between magnetic resonance imaging and clinical outcomes after cartilage repair surgery in the knee: 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.
Trial Detail – UK Clinical Trial Gateway
Please select which trial status you would like to be notified about. Values represent least squares means adjusted for lesion volume and the standard error.
Treatment acrgel symptomatic cartilage defects of the knee: Support Center Support Center. Approximately participants with full-thickness grade III and IV cartilage lesions will be randomised in a 1: One or more of the authors received payments, either directly or indirectly i. Ultimately, the determination of what factors are predictive of clinical outcome following cartilage repair will be multivariate, considering the numerous patient-specific and cartilage lesion—specific variables.
BST-CarGel ® – Smith & Nephew – PDF Catalogs | Technical Documentation
Quantitative T2 mapping of matrix-associated autologous chondrocyte transplantation at 3 Tesla: Which measures symptoms and disabilities most important to postoperative articular cartilage repair patients?
Some have been validated but are insensitive and incomplete. Scores have maximum change of 50 for Pain, 20 for Stiffness, and for Function.
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: Lower numbers represent better outcomes. National Center for Biotechnology InformationU.
Steps can be done by bzt non-sterile nurse while the lesion is being surgically prepared. Baseline demographic characteristics of the 80 patients were similar in the two treatment groups, including age, race, gender, BMI, smoking habits, and activity levels.
Results after microfracture of full-thickness chondral defects in different compartments in the kneeOsteoarthritis Cartilage.
Screening and enrollment into the extension study took place from March to October and the 5-year follow-up was concluded in February A polarized light microscopy method for accurate and reliable grading of collagen organization in cartilage repair. Vst full description of the methodology used in the original 1-year multicenter RCT https: Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.
None of the characteristics were found to be significant covariates leading to bias during bsy analyses, despite reports that clinical outcomes after microfracture are age dependent.
Clin Orthop Relat Res. The response of articular cartilage to mechanical injury. Durability of cartilage repair—does histology matter?
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Change in loaded knee pain single leg squat visual analogue scale VAS ; Baseline to 24 months post-surgery; Change in knee function measured by the TAS questionnaire; Baseline to 24 months post-surgery; Change in knee function measured by the IKDC cargsl Baseline to 24 months post-surgery; Change in knee function measured by the KOOS questionnaire; Baseline to 24 months post-surgery.
Food and Drug Administration. Journal List Cartilage v. Customized bzt resolution pulse sequences specific for morphological or T2 relaxation time analyses of regions of interest were used.
Furthermore, the trial outcomes reported here at 5 years are likely conservative estimates since 2 negative prognosticators, higher BMIs and larger lesions, were found in the enrolled patients compared with those who did not enroll in the extension study, although neither were found to be significant statistical covariates. This procedure creates a natural healing response as a result of the bleeding and clotting caused by the microfracture, restoring the lesion.
Cargle Genet Eng Rev ; Is microfracture of chondral defects in the knee associated with acrgel results in patients aged 40 years or younger? Bdt of microfracture for traumatic chondral defects of the knee: Longitudinal analysis of repeated measures using general estimating equations GEE for the quantity and quality of repair cartilage over 5 years posttreatment.
When it did occur, it was linked to a predisposing factor e. Design The international randomized controlled trial enrolled 80 patients, aged 18 to 55 years, with grade III or IV focal lesions on the femoral condyles. 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.