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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Patients were randomized 1: Clinical efficacy of the microfracture technique for articular cartilage repair in the cargfl Approximately participants with full-thickness grade III and IV cartilage lesions will be randomised in a 1: 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.
cragel The equivalent clinical improvements found in this trial add to accumulating evidence that when performed properly, 9 microfracture can effectively improve clinical caryel 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.
J Bone Joint Surg Br ; Clearly, more and longer studies are required both with structural tools and patient-reported clinical measures that are specific enough cagrel detect improvements following cartilage repair before the relationship between clinical and structural outcomes will emerge. Values represent least squares means adjusted for lesion volume and the standard error. The same follow-up procedures and outcome methodologies were applied in the 5-year extension protocol https: Thank you for helping us grow and improving medical research!
Study Design and Participants The initial 1-year trial 26 enrolled 80 patients at 26 clinical sites. Clin Orthop Relat Res. Is microfracture of chondral defects in the knee associated with different results in patients aged 40 years or younger? caryel
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Knee Surg Sports Traumatol Arthrosc. Microfracture technique versus osteochondral autologous transplantation mosaicplasty in patients with articular chondral lesions of the knee: Pain, Stiffness, and Physical Function.
Pain, Stiffness, and Function in visual analogue scale format: J Bone Joint Surg Br. Consequently, the correlation between repair tissue cargle and clinical outcomes has been elusive.
An analysis of the quality of cartilage repair studies. Support Center Support Center. Investigators and patients were not blinded because of differences in incision size related to treatment. Least squares means are fargel for baseline. This article has been cited by other articles in PMC. Longitudinal analysis of repeated measures using general estimating equations GEE for the quantity and quality of repair cartilage over 5 years posttreatment.
Durability of cartilage repair—does histology matter? All subjects who participated in the initial 1-year trial were asked to provide written informed consent prior to study activities to be part of this extension study, which was approved by the institutional review boards at each of the clinical sites prior to initiation of activities. Customized high—spatial resolution pulse sequences specific for morphological or T2 relaxation time analyses of regions cargell interest were used.
Treatment of full thickness chondral lesions of the knee with microfracture in a group of athletes.
Sample size determination for the 1-year trial was previously reported. Current concepts in the rehabilitation following articular cartilage repair procedures in the knee. Results after microfracture of full-thickness chondral defects in different compartments in the kneeOsteoarthritis Cartilage. Novel scaffold-based BST-CarGel treatment results in superior cartilage repair compared with microfracture in a randomized controlled trial.
Further details and illustrations in Stanish et al. During the 5-year follow-up period, 54 AEs were reported in 31 individual patients, 13 The quantification of lesion and repair biomarkers used proprietary, semiautomated radiologist-corrected morphological segmentation with a programmed anatomical atlas for all knee bone and cartilage structures. T2 MRI of repair cartilage reflects both tissue quality and quantity. Wait 15 minutes to allow implant to clot and maintain its integrity.
Open the catalog to page Data collection and blinded analyses were conducted by third parties as described herein.
A musculoskeletal radiologist with expertise in cartilage repair manually traced the lesion boundaries on the 1-month posttreatment scan, which provided the reference for co-registration with 1- 3- 4- and 5-year scans.
J Bone Joint Surg Am ; J Bone Joint Surgery Am. Some have been validated but are insensitive and incomplete. The full description of the methodology used in the original 1-year multicenter RCT https: The extension study suffered patient loss to follow-up at all planned time points due to several factors, including extremely protracted enrolment periods for both the initial 12 month trial and the extension study, compounded by financial bankruptcy of the original trial sponsor BioSyntech Canada Inc.
Leave undisturbed for a minimum of 10 minutes. Statistical Analysis Sample size determination for the 1-year trial was previously reported. Baseline Characteristics of Patients with 5-Year Data. The advanced bioscaffold technology for enhancing cartilage regeneration A minimally invasive one-step cartilage regeneration system Suited for most cartilage lesion cases Greater quantity and better quality of tissue compared to Microfracture alone The highest standard in cartilage regeneration randomized clinical trials.
Trial Detail – UK Clinical Trial Gateway
Patient profiling in cartilage regeneration: Limited information was released by the patient except that the SAE was ongoing at the time of the 5-year follow-up period. A prospective cohort study.
Repair tissue structure, defined as both the quantity and quality of new tissue, was assessed as the primary outcome. National Center for Biotechnology InformationU.
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.