BST-CarGel® is a first line cartilage repair option used in conjunction with Bone. Marrow Stimulation during a one-step procedure. This bioscaffold, consisting of. Therefore, BST-CarGel was developed to produce a physically stabilized blood clot that is BST-CarGel and its unique characteristics are novel in orthopedics. Consult Smith & Nephew's entire BST-CarGel ® catalogue on MedicalExpo. Page: 1/
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The efficacy and safety of BST-CarGel®, a chitosan scaffold for cartilage repair was BST-CarGel® and microfracture treatment were highly significant over. BST-CarGel® Treatment Maintains Cartilage Repair Superiority over Microfracture at 5 Years in a Multicenter Randomized Controlled Trial. Do not attempt to edit the PDF file (including adding post-it type notes). Within 48 BST-CarGel is a soluble polymer scaffold containing the.
Blood Implants (BST-CarGel).
Operative reports and patient charts were reviewed to assess intraoperative and postoperative complications as well as to obtain the details of surgery, including lesion size and treatment method of the labrum repair vs reconstruction. Results: Thirty-seven patients 37 hips with a mean age of There were 30 male patients, and 20 procedures were performed on the right hip.
The minimum follow-up was 1 year, with a mean follow-up of There were no major adverse events of deep vein thrombosis, blood vessel or nerve damage, hemarthrosis, arthralgia, or device-related adverse events.
Two patients 5. At 1 year postoperatively, there were statistically significant improvements in the iHOT Conclusion: The arthroscopic treatment of chondral acetabular defects with BST-CarGel demonstrates a satisfactory safety profile, with statistically significant improvement in patient-reported clinical outcome scores, even for those with very large chondral defect sizes.
Keywords: arthroscopic surgery, hip, acetabulum, cartilage, clinical outcome, chondral defect Osteoarthritis of the hip is a disabling condition, which leads to large burdens on patients and society. Microfracture is a standard treatment for small chondral defects, with good results and low complication rates.
These cells are stabilized by a bone marrow clot and differentiate into stable fibrocartilaginous tissue. Philippon and colleagues 16 assessed 9 patients with full-thickness chondral defects who underwent microfracture via hip arthroscopic surgery.
McDonald and colleagues 12 showed that professional hockey players who underwent microfracture for Outerbridge grade 4 chondral lesions were able to return to competitive games without a statistically significant decrease in performance when compared with the matched control cohort. The BST-CarGel and blood mixture then solidifies in the cartilage defect, forming a 3-dimensional scaffold for the repair process by stabilizing the clot in the cartilage lesion via adhesion and inhibition of clot retraction.
The primary purpose of this study was to assess the safety profile of the hip in patients who underwent arthroscopic microfracture in conjunction with BST-CarGel through a retrospective chart review. The secondary objective was to conduct a retrospective analysis of prospectively collected early clinical outcome data on patients who underwent arthroscopic microfracture in conjunction with BST-CarGel for femoral head chondral defects.
Therefore, the case log of the senior surgeon I. 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.Conclusion At 5 years post-treatment, patients treated with BST-CarGel demonstrated sustained and significantly superior durability of repair over microfracture for repair tissue quantity and quantity.
At 1 year postoperatively, there were statistically significant improvements in the iHOT The chitosan-based biomatrix device is mixed with autologous whole blood and is applied to the microfractured cartilage lesion in which it physically stabilises the clot and guides and enhances marrow-derived repair to promote hyaline cartilage regeneration. The safety definitions used during this trial conformed to international regulatory norms for clinical trials investigating medical devices.
In these cases, the patients are given an option to return to the operating room for revision hip arthroscopic surgery with microfracture and BST-CarGel application.
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.