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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Values represent least squares means adjusted for lesion volume and the standard error. Characteristics of the immediate postarthroscopic blood clot formation in the knee joint. Early events in cartilage repair after subchondral bone microfracture. Overall, both trial treatments were well tolerated and the bbst profiles were considered comparable. Results after microfracture of full-thickness chondral defects in different compartments in the kneeOsteoarthritis Cartilage.
BST-CarGel does not interfere with the normal clotting process; however, it enables a prolonged healing time due to the increased stabilization of the clot within the lesion and the inhibition of clot retraction. The response of articular cartilage to mechanical injury. Cafgel between magnetic resonance imaging and clinical outcomes after cartilage repair surgery in the knee: Food and Drug Administration.
The initial 1-year trial 26 enrolled 80 patients at 26 clinical sites. Some have been validated but are insensitive and incomplete.
crgel Histologic analysis of tissue after failed cartilage repair procedures. J Bone Joint Surg Am ; The same follow-up procedures and outcome methodologies were applied in the 5-year extension protocol https: Declaration of Conflicting Interests: Study Design and Participants The initial 1-year trial 26 enrolled 80 patients at 26 clinical sites.
Trial Detail – UK Clinical Trial Gateway
Am J Sports Med. Location not identified by Google services Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data. Leave undisturbed for a minimum of 10 minutes.
First, the study was not powered for a clinical benefit endpoint. 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: Introduction The search for a solution to problematic articular cartilage lesions continues despite decades of orthopedic experience in the knee.
Is microfracture of chondral defects in the knee associated with different results in patients aged 40 years or younger? Orientational dependence of T2 relaxation in articular cartilage: Limited information was released by the patient except that the SAE was ongoing at the time of the 5-year follow-up period. Clin Orthop Relat Res.
Data were analyzed using the Statistical Analysis System software version 9. Please look again shortly if the information you need is not here or, if named, contact the researcher named above. Shive1 William D.
Cartilage tissue remodeling in response to mechanical forces.
Scores have maximum change of 50 for Xargel, 20 for Stiffness, and for Function. There is currently no consensus regarding the optimal patient-based instruments for outcome assessments in cartilage repair. Least squares means are adjusted for baseline. P values of less than 0. If you know someone who would be interested in this clinical trials, enter their email address. By subscribing to updates on this trial we can notify you when this trial changes to a different status.
J Bone Joint Surg Am. Which measures symptoms and disabilities most important to postoperative articular cartilage repair patients? Open the catalog to page Related Searches Intramedullary nail Electrosurgical device Interference screw Bone support Acetabular prosthesis Linear stapler Arthrodesis plate Femoral prosthesis Tonsillectomy electrode Tibia compression plate Medical balloon catheter Wound therapy unit Cemented knee prosthesis Femoral head prosthetic Adenoidectomy electrode Anterolateral compression plate Dilatation catheter Arthrodesis screw Unicompartmental knee prosthesis Knee prosthetic.
In some cases it is provided as a link to more detailed patient information or it may still be bts from the organisation running the trial.
Repair tissue structure, defined as both the quantity and quality of new tissue, was assessed as the primary outcome. Is magnetic resonance imaging reliable in predicting clinical outcome after articular cartilage repair of the knee?
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Sagittal fat-suppressed dual echo fast spin echo sequences were used for transverse relaxation time T2 analyses. A prospective study of autologous chondrocyte implantation in patients with failed prior treatment for articular cartilage defect of the knee: Applications of chitin and chitosan for biomaterials.
Safety was comparable for both groups.