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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Factors predictive of outcome 5 years after matrix-induced autologous chondrocyte implantation in the tibiofemoral joint. Osteochondral autologous transplantation versus microfracture for the treatment of articular cartilage defects in the knee joint in athletes.
J Bone Joint Surg Am. The advanced bioscaffold technology for enhancing cartilage regeneration A minimally invasive one-step cartilage regeneration system Suited for most cartilage lesion cases Cxrgel quantity and better quality of tissue compared to Microfracture alone The highest standard in cartilage regeneration randomized clinical trials.
The adverse effect of elevated body mass index on outcome after autologous chondrocyte implantation. Clin Orthop Relat Res. You are cqrgel them the link for the trial open on this page. Open the catalog to page 7. Novel scaffold-based BST-CarGel treatment results in superior cartilage repair compared with microfracture in a randomized controlled trial.
Go back to results. Prospective clinical study of autologous chondrocyte implantation and correlation with MRI at three and 12 months. J Bone Joint Surg Am. Only 2 patients had complete cafgel for 1, 2, 3, 4, and 5 years. Steps can be done by a non-sterile nurse while the lesion is being surgically prepared. Food and Drug Administration. Further details and cargeel in Stanish et al. 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.
Furthermore, repair tissue structure represents a reliable clinical trial endpoint since hyaline cartilage has an exquisite structure characterized by hallmark features, including collagen content and zonal organization, glycosaminoglycan, and cell population, 69 which can be easily discriminated by highly accurate quantitative measures sensitive to early changes in cartilage structure under reasonable clinical trial time frames.
Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data. Scores have maximum value of 50 for Pain, 20 for Stiffness, and for Function. Safety was comparable for both groups.
The tertiary endpoint was cargeo Medical Outcomes Study Item Short-Form Health Survey version 2 SF30 which includes 2 aggregate measures, the physical and mental components, derived from 8 subscales. Secondary and Tertiary Outcomes Clinical benefit was evaluated as a secondary outcome at initiation, 2, 3, 4, gst 5 years posttreatment using the WOMAC questionnaire consisting of 3 subscales: Structural characteristics of the collagen network in human normal, degraded and repair articular cartilages observed in polarized carge and scanning electron microscopies.
Wait 15 minutes to allow implant to clot and maintain its integrity. A statistical comparison of baseline characteristics of those patients who did not enroll into the extension enrolment with those who did, found that enrolled patients had significantly higher BMIs, larger treated lesion areas, and attended more posttreatment physiotherapy sessions than those that did not enroll, but were similar for all other parameters.
An analysis of the quality of cartilage repair studies. Annu Rev Biomed Eng. Second, optimal MFX surgical technique was strictly obeyed in both groups. The natural history of cartilage defects in people with knee osteoarthritis. The international randomized controlled trial enrolled 80 patients, aged 18 to 55 years, with grade III or IV focal lesions on the femoral condyles.
Data collection and blinded analyses were conducted by third parties as described herein. Cell origin and differentiation in the repair of full-thickness defects of articular cartilage.
Trial Detail – UK Clinical Trial Gateway
Characteristics of the immediate postarthroscopic blood clot formation in the knee joint. J Bone Joint Surg Br.
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.
B Repair tissue T2 relaxation times: 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. Dashed line represents mean ipsilateral native cartilage T2 value. The response of articular cartilage to mechanical injury. Is magnetic resonance imaging reliable in predicting clinical outcome after articular cartilage repair of the knee? The initial 1-year trial 26 enrolled 80 patients at 26 clinical sites.
Values represent means and standard errors.