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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Trial source and source ID number. This interpretation for T2 MRI and its relationship to collagen organization is substantiated by a previous statistical correlation between T2 and polarized light microscopy scoring of 38 repair tissue biopsies retrieved at 1 year posttreatment in this same study.
This information is designed to help you decide whether this trial is of interest. Patient profiling in cartilage regeneration: This is in the inclusion criteria above. Concentrated bone marrow aspirate improves full-thickness cartilage repair compared with microfracture in the equine model. Piramal Healthcare Canada Ltd. Pain, Stiffness, and Physical Function.
Microfracture to treat full-thickness chondral defects: J Bone Joint Surg Am.
Is microfracture of chondral defects in the knee associated with different results in patients aged 40 years or younger? Early events in cartilage repair after subchondral bone microfracture. Factors predictive of outcome 5 years after matrix-induced autologous chondrocyte implantation in the tibiofemoral vargel.
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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.
Declaration of Conflicting Interests: The baseline characteristics for the patients included in this 5 year analysis were generally well-balanced, except for a few notable exceptions: Consequently, the correlation between repair tissue structure and clinical outcomes has been elusive.
Trial Detail – UK Clinical Trial Gateway
Screening and enrollment into the extension study took place from March to October and the 5-year follow-up was concluded in February One or more of the authors received payments, either directly or indirectly i. No patient in either treatment group was discontinued from the study because of an AE, SAE, or incident. J Bone Joint Surg Br.
General estimating equations were used for longitudinal statistical analysis of repeated measures. Quantitative T2 mapping of matrix-associated autologous chondrocyte transplantation at 3 Tesla: Unique to this trial was the new level of evidence brought by the use of validated 3-dimensional quantitative MRI, which assessed the structural outcomes of repair tissue quantity and quality over 5 years with a high level of standardization and precision not previously achieved in a Good Clinical Practice—compliant RCT for cartilage repair.
The safety definitions used during this trial conformed to international regulatory norms for clinical trials investigating medical devices.
P values of less than 0.
The search for a solution to problematic articular cartilage lesions continues despite decades of orthopedic experience in the knee. Lower numbers represent better outcomes. Second, optimal MFX surgical technique was strictly obeyed in both groups. J Bone Joint Surgery Am.
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. Osteochondral autologous transplantation versus microfracture for the treatment of articular cartilage defects in the knee joint in athletes. Five-year outcome of characterized chondrocyte implantation versus microfracture for symptomatic cartilage defects of the knee: Safety Overall, both trial treatments were well tolerated and cargep safety profiles were considered comparable.
None of the current repair procedures, cragel include bone marrow stimulation, cultured cell-based therapies, and grafting, have been studied sufficiently, particularly in the mid to long term yearsto fully understand which factors dictate longer term outcomes for this troublesome pathology. Chitosan chemistry and pharmaceutical perspectives.
Study Design and Participants The initial 1-year trial 26 enrolled 80 patients at 26 clinical sites. Investigators and patients were not blinded because of differences in incision size related to treatment. Clinical efficacy of the microfracture technique for articular cartilage repair in the knee: Several studies have reported relationships between structural assessments and long-term clinical outcomes, but these studies suffer from bsst sample sizes, statistical rigor, and subjective scoring of both the structural and the clinical components.
Open the catalog to page 8. Shive 1 Piramal Healthcare Canada Ltd.
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Quantitative 3D MRI reveals limited intra-lesional bony overgrowth at 1 year after microfracture-based cartilage repair. Support Center Support Center. BST-CarGel Piramal Life Sciences, Bio-Orthopaedic Divisiona liquid chitosan-containing polymer scaffolding, has been developed as an intra-articular injectable scaffold to aid in the stabilization of the blood clot created by microfracture. 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.
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.
Matrix-applied characterized autologous cultured chondrocytes versus microfracture: By subscribing to updates on this trial we can notify you when this trial changes to a different status. Check availability of results on the Clinicaltrials. Longitudinal analysis of repeated measures using general estimating equations GEE for the quantity and quality of repair cartilage over 5 years posttreatment. Collagen of articular cartilage.
For morphological analyses of cartilage, cartilage lesions and bone, both bwt and sagittal 3-dimensional fat-suppressed spoiled gradient echo SPGRand sagittal 3-dimensional gradient echo GRE sequences were used. There were no deaths over the 5-year period of the study. The trial was single-blind since the independent third party carrying out the analyses of primary endpoints was unaware of patient treatment.