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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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.
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Support Center Support Center. Open the catalog to page 7. 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.
Mean T2 is derived from the entire repair cartilage volume. 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.
Trial Detail – UK Clinical Trial Gateway
An analysis of the quality carrgel cartilage repair studies. Microfracture for knee chondral defects: Autologous chondrocyte implantation compared with microfracture in the knee. Factors predictive of outcome 5 years after matrix-induced autologous chondrocyte implantation in the tibiofemoral joint. This investigation was performed at 26 clinical sites in Canada, Spain, and South Korea complete list is given in the Acknowledgments section.
Pain, Stiffness, and Physical Function. Durability of cartilage repair—does histology matter? Baseline Characteristics of Patients with 5-Year Data. BST-CarGel does not interfere with the normal clotting 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. One or more of the authors received payments, either directly or indirectly i.
The trial was single-blind since the independent third party carrying out the analyses of primary endpoints was unaware of patient treatment. Go back to results. J Orthop Sports Phys Ther. 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.
Structural characteristics of the collagen network in human normal, degraded and repair articular cartilages observed in polarized light and scanning electron microscopies. The Online Medical Device Exhibition. 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.
Statistical Analysis Sample size determination for the 1-year trial was previously reported. When it did occur, it was linked to a predisposing factor e.
All questionnaires cargsl provided to patients during on-site study visits or by mail as needed. Am J Sports Med. Declaration of Conflicting Interests: Outcomes of microfracture for traumatic chondral defects of the knee: Check availability of results on the Clinicaltrials.
Osteochondral autologous transplantation versus microfracture for the treatment of articular cartilage defects in the knee joint in athletes. Adheres to the cartilage lesion surfaces.
Cell origin and differentiation in the repair of full-thickness defects of articular cartilage. Safety was comparable for both groups. Values represent mean change from baseline adjusted for baseline and standard errors.