BST CARGEL PDF

Appointement CarGel As in all joints, the cartilage in the knees covers the ends of the bones. It cushions the bones so that the joints can move easily. If cartilage is damaged, it cannot regenerate on its own. This combined approach promotes cartilage regeneration in isolated cartilage injuries. The technique is not suitable for treating osteoarthritis. BST-CarGel in A minimally invasive, one-stage method of cartilage regeneration Suitable for most isolated cartilage injuries not suitable for osteoarthritis Results in a greater quantity and quality of cartilaginous tissue than microfracture surgery alone the most commonly used technique Highest standards of randomized clinical trials on cartilage regeneration Why do we need a cartilage repair treatment?

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Matthew S. Email: moc. This report was undertaken to investigate 5-year structural and clinical outcomes. 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. General estimating equations were used for longitudinal statistical analysis of repeated measures.

Safety was comparable for both groups. Keywords: cartilage repair, chitosan, quantitative MRI, microfracture, scaffold Introduction The search for a solution to problematic articular cartilage lesions continues despite decades of orthopedic experience in the knee. 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 years , to fully understand which factors dictate longer term outcomes for this troublesome pathology.

Microfracture MFX , the de facto standard of care and the most commonly used first-line surgical treatment 6 , 7 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. Chitosan is an abundant glucosamine polysaccharide found in the exoskeleton of crustaceans and has many desirable biomaterial properties. Study Design and Participants The initial 1-year trial 26 enrolled 80 patients at 26 clinical sites.

The trial was single-blind since the independent third party carrying out the analyses of primary endpoints was unaware of patient treatment. Investigators and patients were not blinded because of differences in incision size related to treatment.

The extension protocol was originally designed to provide longer term follow-up at 2, 3, 4, and 5 years and followed identical outcome measures. 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.

Outcome Measures Primary Outcome Repair tissue structure, defined as both the quantity and quality of new tissue, was assessed as the primary outcome. Standardized 1. Customized high—spatial resolution pulse sequences specific for morphological or T2 relaxation time analyses of regions of interest were used. For morphological analyses of cartilage, cartilage lesions and bone, both coronal and sagittal 3-dimensional fat-suppressed spoiled gradient echo SPGR , and sagittal 3-dimensional gradient echo GRE sequences were used.

Sagittal fat-suppressed dual echo fast spin echo sequences were used for transverse relaxation time T2 analyses. All blinded scans were sent to imaging core labs for centralized scan quality review and storage VirtualScopics, Rochester, NY and blinded quantitative analysis Qmetrics Technologies, Rochester, NY using validated techniques.

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. 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.

Debrided lesions quantified using 1-month posttreatment scans represented baseline values for lesion surface area and volume. Further details and illustrations in Stanish et al. 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: Pain, Stiffness, and Physical Function.

Safety was assessed through recording of all adverse events AEs up to 5 years posttreatment. The safety definitions used during this trial conformed to international regulatory norms for clinical trials investigating medical devices.

The tertiary endpoint was the Medical Outcomes Study Item Short-Form Health Survey version 2 SF , 30 which includes 2 aggregate measures, the physical and mental components, derived from 8 subscales. All questionnaires were provided to patients during on-site study visits or by mail as needed. Statistical Analysis Sample size determination for the 1-year trial was previously reported. The bootstrap method was used to account for sample size differences. Data were analyzed using the Statistical Analysis System software version 9.

All reported P values are 2-sided. P values of less than 0. Results Enrollment and Baseline Characteristics of the Patients Screening and enrollment for the initial 1-year trial took place from May to January , and 1-year follow-up was concluded in February Screening and enrollment into the extension study took place from March to October and the 5-year follow-up was concluded in February 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.

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 into the extension study. Only 2 patients had complete data for 1, 2, 3, 4, and 5 years. 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.

Table 1. Baseline Characteristics of Patients with 5-Year Data.

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