BST CARGEL PDF


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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Mean T2 is derived from the entire repair cartilage volume. Patient profiling in cartilage regeneration: Factors predictive of outcome 5 years after matrix-induced autologous chondrocyte implantation in the tibiofemoral joint.

Which measures symptoms and disabilities most important to postoperative articular cartilage repair patients?

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. Approximately participants with full-thickness grade III and IV cartilage lesions will be randomised in a 1: Microfracture MFXthe de facto standard of care and the most commonly used first-line surgical treatment 67 for small cartilage lesions, is the deliberate penetration of the subchondral bone below a cartilage lesion to elicit bleeding and a subsequent bone marrow—derived repair response.

Repair tissue structure, defined as both the quantity and quality of new tissue, was assessed as the primary outcome.

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An analysis of the quality of cartilage repair studies. J Bone Joint Surg Am. This report was undertaken to investigate 5-year structural and clinical outcomes. Sample size determination for the 1-year trial was previously reported. The same follow-up procedures and outcome methodologies were applied in the 5-year extension protocol https: By subscribing to updates on this trial we can notify you when this trial changes to a different status.

There is currently no consensus regarding the optimal patient-based instruments for outcome assessments vst cartilage repair.

Clearly, more and longer studies are required both with structural tools and patient-reported clinical measures that are specific enough to detect improvements following cartilage repair before the relationship between clinical and structural outcomes will emerge. Annu Rev Biomed Eng. Magnetic resonance observation of cartilage repair tissue MOCART for the evaluation of autologous cargeo transplantation: This investigation was performed at 26 clinical sites in Canada, Spain, and South Korea complete list is given in the Acknowledgments section.

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A randomized trial comparing autologous chondrocyte implantation with microfracture. One or more of the authors received payments, either directly or indirectly i.

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.

Safety was comparable for both groups. Open the catalog to page 7. 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 points prior to enrolling carge the extension study. 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: 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 yearsczrgel fully understand which factors dictate longer term outcomes for this troublesome pathology.

Trial Detail – UK Clinical Trial Gateway

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. 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 Collagen of articular cartilage.

Open the catalog to page When it did occur, it was linked to a predisposing factor e. Quantitative 3D MRI reveals limited intra-lesional bony overgrowth at 1 year after microfracture-based cartilage repair. Piramal Healthcare Canada Ltd. Data were analyzed using the Statistical Analysis System software version 9.

J Bone Joint Surg Br ; Novel scaffold-based BST-CarGel treatment results in superior cartilage repair compared with microfracture in a randomized controlled trial. All questionnaires were cargsl to patients during on-site study visits or by mail as needed. Clinical benefit was evaluated as a secondary outcome at cagel, 2, 3, 4, and 5 years posttreatment using the WOMAC questionnaire consisting of 3 subscales: The tertiary endpoint was the Medical Outcomes Study Item Short-Form Cragel Survey version 2 SF30 which includes 2 aggregate measures, the physical and mental components, derived from 8 subscales.

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Scores have maximum cargwl of 50 for Pain, 20 for Stiffness, and for Function. Introduction The search for a solution to problematic articular cartilage lesions continues despite decades of orthopedic experience in the knee. Study Design and Participants The initial 1-year trial 26 enrolled csrgel patients at 26 clinical sites. Is magnetic resonance imaging reliable in predicting clinical outcome after articular cartilage repair of the knee?

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. 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.

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data. Outcomes of microfracture for traumatic chondral defects of the knee: The baseline characteristics for the patients included in this 5 year analysis were generally well-balanced, except for a few notable exceptions: Trial source and source ID number.

Overall, both trial treatments were well tolerated and the safety profiles were considered comparable. Cartilage MRI T2 relaxation time mapping: Author information Copyright and License information Disclaimer. Screening and enrollment for the initial 1-year trial took place from May to Januaryand 1-year follow-up was concluded in February