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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Unique to this trial was the new level of evidence brought by the use of validated bbst quantitative MRI, which assessed the structural outcomes of repair tissue quantity and quality over 5 years with a high level of standardization and precision not previously achieved in a Good Clinical Practice—compliant RCT for cartilage repair.
Microfracture to treat full-thickness chondral defects: Only 2 patients had complete data for 1, 2, 3, 4, and 5 years. 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.
J Orthop Surg Res. This report was undertaken to investigate 5-year structural and clinical outcomes.
Durability of cartilage repair—does histology matter? Five-year outcome of characterized chondrocyte implantation versus microfracture for symptomatic cartilage defects of the knee: This article has been cited by other articles in PMC.
A systematic review and meta-analysis. Limitations and sources of bias in clinical knee cartilage research. Ultimately, the determination carrgel what factors are predictive of clinical outcome following cartilage repair will be multivariate, considering the numerous patient-specific and cartilage lesion—specific variables.
None of the current repair procedures, which include bone marrow stimulation, cultured cell-based therapies, and grafting, have been studied sufficiently, particularly in the mid to long term yearsto fully understand which factors dictate longer cargfl outcomes for this troublesome pathology.
BST-CarGel ® – Smith & Nephew – PDF Catalogs | Technical Documentation
Go back to results. Least squares means are adjusted for baseline. Some have been validated but are insensitive and incomplete. The response of articular cartilage to mechanical injury. The initial 1-year trial 26 enrolled 80 patients at 26 clinical sites. A prospective study of autologous chondrocyte implantation in patients with failed prior treatment for articular cartilage defect of the knee: Orientational dependence of T2 relaxation in articular cartilage: Characteristics of the immediate postarthroscopic blood clot formation in the knee joint.
Thus, with clinical benefit being shown at acceptable levels for most cartilage repair therapies 33346768 and for significantly long follow-up periods, superiority of one therapy or technique falls to the structure of the replaced or cargeo cartilage within the lesion, such as was found in this trial. When it did occur, it was linked to a predisposing factor e. Repair tissue quantity and quality; Up to 24 months post-surgery; Adverse events cragel 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.
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: Longitudinal analysis of repeated measures cadgel general estimating equations GEE for the quantity and quality of repair cartilage over 5 years posttreatment. Open the catalog to page 8.
Trial Detail – UK Clinical Trial Gateway
Is magnetic resonance imaging reliable in predicting clinical outcome after articular cartilage repair of the knee? Support Center Support Center. Adheres to the cartilage lesion surfaces. An analysis of the quality of cartilage repair studies. Treatment of full thickness chondral lesions of the knee with microfracture in a group of athletes. The 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 carrgel excessive intralesional bony overgrowth.
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J Bone Joint Surgery Am. Novel injectable neutral solutions of chitosan form biodegradable gels in situ. For morphological analyses of cartilage, cartilage lesions and bone, both coronal and sagittal 3-dimensional fat-suppressed spoiled gradient echo SPGRand sagittal 3-dimensional gradient echo GRE sequences were used.