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.

Author: Gardakora Sakasa
Country: Italy
Language: English (Spanish)
Genre: Sex
Published (Last): 19 October 2012
Pages: 245
PDF File Size: 1.92 Mb
ePub File Size: 18.1 Mb
ISBN: 584-3-74772-865-5
Downloads: 40894
Price: Free* [*Free Regsitration Required]
Uploader: Yozshukinos

Please select which trial status you would like to be notified about.

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. 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. A possible explanation of the reported short-term success MFX could be the fact that orthopedic surgeons practicing MFX are often not performing critical steps of the technique as published originally by Steadman csrgel al.

Findings at five years. Novel injectable neutral solutions of chitosan form biodegradable gels in situ. Data were analyzed using the Statistical Analysis System software version 9. Baseline Characteristics of Patients with 5-Year Data.

Outcomes of microfracture for traumatic chondral defects of the knee: Statistical Analysis Sample size determination for the 1-year trial was previously reported. Patient profiling in cartilage regeneration: An analysis of the quality of cartilage repair studies.

There was a problem providing the content you requested

The safety definitions used during this trial conformed to international regulatory norms for clinical trials investigating medical devices. Autologous chondrocyte implantation compared with microfracture in the knee.

Several studies have reported relationships between structural assessments and long-term clinical outcomes, but these studies suffer from small sample sizes, statistical rigor, and subjective scoring of both the structural and the clinical components.

First, the study was not powered for a clinical benefit endpoint. Concentrated bone marrow aspirate improves full-thickness cartilage repair compared with microfracture in the equine model.


Wait 15 minutes to allow implant to clot and maintain its integrity. Mean T2 is derived from the entire repair cartilage volume. Only 2 fargel had complete data for 1, 2, 3, 4, and 5 years. J Bone Joint Surg Br. Author information Copyright and License information Disclaimer. Biotechnol Genet Eng Rev ; Previous studies have been limited to subjective semiquantitative MRI analysis using MOCART 64 or Henderson scores 65 and none used quantitative 3-dimensional analysis for structural assessments as described in this study.

Prospective clinical study of autologous chondrocyte implantation and correlation with MRI at three and 12 months. Hambly K, Griva K. Effects of calcified cartilage on healing of chondral defects treated with microfracture in horses. Microfracture for knee chondral defects: You are sending them the link for the trial open on this page. It can be easily argued that a sufficient quantity of repair cartilage with hyaline features enables appropriate articulation, biomechanical loading, and tissue metabolism, which would be necessary for long-term durability and function.

A statistical comparison bsr 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.

Structural characteristics of the collagen network in human normal, degraded and repair articular cartilages observed in polarized light and scanning electron microscopies.

BST-CarGel ® – Smith & Nephew – PDF Catalogs | Technical Documentation

Declaration of Conflicting Interests: 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 Annu Rev Biomed Eng.

All questionnaires were provided to patients during on-site study visits or by mail as needed. The delayed initiation of the extension cadgel 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. During the 5-year follow-up period, 54 AEs were reported in 31 individual patients, 13 Shive1 William D.


Longitudinal analysis of repeated measures using general estimating equations GEE for the quantity and quality of repair cartilage over 5 years posttreatment. No patient in either treatment group bstt discontinued from the study because of an AE, SAE, or incident. Change in loaded knee pain single leg squat visual analogue scale VAS ; Baseline to 24 months post-surgery; Change in knee cargell measured by the TAS questionnaire; Baseline to 24 months post-surgery; Change in knee function measured by the IKDC questionnaire; Baseline to 24 months carbel Change in knee function carfel by the KOOS questionnaire; Baseline to 24 months post-surgery.

Screening and enrollment for the initial 1-year trial took place from May to Januaryand 1-year follow-up was concluded in February Osteochondral autologous transplantation versus microfracture for the treatment of articular cartilage defects in the knee joint in athletes.

Trial Detail – UK Clinical Trial Gateway

Crgel Bone Joint Surg Cargeel. National Center for Biotechnology InformationU. Knee Surg Sports Traumatol Arthrosc. 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.

Caggel RECORD trial is a multi-centre, randomized, controlled trial to assess the impact of the BST-CarGel scaffold and microfracture versus microfracture alone on short term clinical benefit as measured by loaded knee pain single leg squat on a visual analogue scale monthsmid-long term clinical benefit as measured by the same loaded knee pain single leg squat 9, 12, and 24 months and Tegner Activity Score TASInternational Knee Documentation Committee IKDCand Knee Injury and Osteoarthritis KOOS at 3, 6, 9, 12 and 24 months post-operatively.