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.
J Bone Joint Surg Am ; It can be easily argued that a sufficient quantity of repair cartilage with hyaline features enables appropriate articulation, biomechanical loading, and tissue metabolism, which would be necessary for long-term durability and function.
During the 5-year follow-up period, 54 AEs were reported in 31 individual patients, 13 Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.
Which measures symptoms and disabilities most important to postoperative articular cartilage repair patients? The bootstrap method was used to account for sample size differences.
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 caegel initial 12 month trial and the extension study, compounded by financial bankruptcy of the original trial sponsor BioSyntech Canada Inc.
T2 relaxation reveals spatial collagen architecture in articular cartilage: Outcome Measures Primary Outcome Repair tissue structure, defined as both the quantity and quality of new tissue, was assessed as the primary outcome.
The delayed initiation of the extension study regretfully allowed all but 4 patients to surpass their 2-year follow-up time point, and many others to pass their 3- 4- and 5-year time cafgel prior to enrolling into the extension study. A systematic review and meta-analysis. This information is designed to help you decide whether this trial is of interest. 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 cargl 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.
The Online Medical Device Exhibition. 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.
Patients were randomized 1: Author information Copyright and License information Disclaimer. The same follow-up procedures and outcome methodologies were applied in the 5-year extension protocol https: Please look again shortly if the information you need is not here or, if named, contact the researcher named above. Study Design and Participants The initial 1-year trial 26 enrolled 80 patients at 26 clinical sites. The adverse effect acrgel elevated body mass index on outcome after autologous chondrocyte implantation.
Data collection and blinded analyses were conducted by third parties as described herein.
Baseline Characteristics of Patients with 5-Year Data. 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 Enrollment and Baseline Characteristics of the Patients Screening and enrollment for the initial 1-year trial took place from May to Januaryand 1-year follow-up was concluded in February Limitations and sources of bias in clinical knee cartilage research.
Repair tissue quantity and quality; Up to 24 months post-surgery; Adverse events related 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.
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Pain, Stiffness, and Physical Function. The full description of the methodology used in the original 1-year multicenter RCT https: Results after microfracture of full-thickness chondral defects in different compartments in the kneeOsteoarthritis Cartilage.
The current standard of treatment for cartilage lesions on the femoral condyle is microfracture, which is conducted by penetrating the subchondral bone below the lesion.
The search for a solution to problematic articular cartilage lesions continues despite decades of orthopedic experience in the knee. Previous studies have been limited to subjective semiquantitative MRI analysis using MOCART 64 or Henderson scores 65 and none used quantitative 3-dimensional analysis for structural assessments as described in this study.
Clinical efficacy of the microfracture technique for articular cartilage repair in the knee: Screening and enrollment for the initial 1-year trial took place from May to Januaryand 1-year follow-up was concluded in February Open the catalog to page 9. This procedure creates a natural healing response as a result of the bleeding and clotting caused by the microfracture, restoring the lesion.
J Orthop Surg Res. The advanced bioscaffold technology for enhancing cartilage regeneration A minimally invasive one-step caggel 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.
By subscribing to updates on this trial we can notify you when this trial changes to a different status. None of the characteristics were found to cragel significant covariates leading to bias during sensitivity cargfl, despite reports that clinical outcomes after microfracture are age dependent.
Findings at five years. 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 questionnaire; Baseline to 24 months post-surgery; Change in knee function measured by the KOOS questionnaire; Baseline to 24 months post-surgery.
BST-CarGel ® – Smith & Nephew – PDF Catalogs | Technical Documentation
Trial source and source ID number. Correlation between magnetic resonance imaging and clinical outcomes after cartilage repair surgery in the knee: Open the catalog to page 8.
Histologic analysis of tissue after failed cartilage repair procedures. 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: Treatment of symptomatic cartilage defects of the knee: All questionnaires were provided to patients during on-site study visits or by mail as needed.
Applications of chitin and chitosan for biomaterials. Shive1 William D. 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. Go back to results.
Study of the collagen structure in the superficial zone and physiological state of articular cartilage using a 3D confocal imaging technique. This multi-centre czrgel, 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.
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