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Bone & Joint Research
Vol. 12, Issue 3 | Pages 179 - 188
7 Mar 2023
Itoh M Itou J Imai S Okazaki K Iwasaki K

Aims

Orthopaedic surgery requires grafts with sufficient mechanical strength. For this purpose, decellularized tissue is an available option that lacks the complications of autologous tissue. However, it is not widely used in orthopaedic surgeries. This study investigated clinical trials of the use of decellularized tissue grafts in orthopaedic surgery.

Methods

Using the ClinicalTrials.gov (CTG) and the International Clinical Trials Registry Platform (ICTRP) databases, we comprehensively surveyed clinical trials of decellularized tissue use in orthopaedic surgeries registered before 1 September 2022. We evaluated the clinical results, tissue processing methods, and commercial availability of the identified products using academic literature databases and manufacturers’ websites.


Bone & Joint 360
Vol. 11, Issue 2 | Pages 31 - 34
1 Apr 2022


The Bone & Joint Journal
Vol. 104-B, Issue 1 | Pages 91 - 96
1 Jan 2022
Modi A Haque A Deore V Singh HP Pandey R

Aims. Long-term outcomes following the use of human dermal allografts in the treatment of symptomatic irreparable rotator cuff tears are not known. The aim of this study was to evaluate these outcomes, and to investigate whether this would be a good form of treatment in young patients in whom a reverse shoulder arthroplasty should ideally be avoided. Methods. This prospective study included 47 shoulders in 45 patients who underwent an open reconstruction of the rotator cuff using an interposition GraftJacket allograft to bridge irreparable cuff tears, between January 2007 and November 2011. The Oxford Shoulder Score (OSS), pain score, and range of motion (ROM) were recorded preoperatively and at one year and a mean of 9.1 years (7.0 to 12.5) postoperatively. Results. There was significant improvement in the mean OSS from 24.7 (SD 5.4) preoperatively to 42.0 (SD 6.3) at one year, and this improvement was maintained at 9.1 years (p < 0.001), with a score of 42.8 (SD 6.8). Similar significant improvements in the pain score were seen and maintained at the final follow-up from 6.1 (SD 1.6) to 2.1 (SD 2.3) (p < 0.001). There were also significant improvements in the ROM of the shoulder, and patient satisfaction was high. Conclusion. The use of an interposition human dermal allograft in patients with an irreparable rotator cuff tear leads to good outcomes that are maintained at a mean of nine years postoperatively. Cite this article: Bone Joint J 2022;104-B(1):91–96


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 168 - 168
1 Sep 2012
Wong IH Burns J Snyder S
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Purpose. Management of massive, degenerative, and irreparable rotator cuff tears is challenging. Excessive re-tear rates and poor clinical outcome after standard repair have led to alternative methods of treatment. Tendon transfers and shoulder arthroplasty have had mixed results; both are invasive procedures with high potential morbidity. We began performing rotator cuff augmentation and replacement using GraftJacket allograft acellular human dermal matrix as a biologic minimally invasive alternative in this difficult population almost 6 years ago. This article highlights our preferred arthroscopic technique and early results. Method. From January 2004 to June 2007, 45 patients (36 men, 9 women) with massive rotator cuff tears were treated arthroscopically with the GraftJacket allograft. All patients completed a preoperative University of California, Los Angeles (UCLA) score. Follow-up was a minimum of 2 years (range, 24–68 months) and patients completed UCLA, Western Ontario Rotator Cuff (WORC), and American Shoulder and Elbow Surgeons (ASES) scores. Results. Analysis was performed using the 3 validated outcomes measurement scores. The mean UCLA score increased from 18.4 preoperatively to 27.5 postoperatively (P < .000). The average WORC score was 75.2, and the ASES score was 84.1 at the final follow-up. Conclusion. Evidence-based data to outline an algorithm for management of irreparable rotator cuff tears is being developed. We documented significant clinical improvement with arthroscopic rotator cuff reconstruction using the GraftJacket allograft acellular human dermal matrix. The procedure is safe and associated with high patient satisfaction, without the morbidity of tendon transfer or arthroplasty. For those few cases where further surgery is required, no bridges are burned. The early success of this procedure warrants further study with more patients, longer follow-up, and higher levels of evidence-based investigation


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XVIII | Pages 42 - 42
1 May 2012
Chaudhury S Holland C Porter D Vollrath F Carr AJ
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Background. High re-rupture rates following repairs of rotator cuff tears (RCTs) have resulted in the increased use of repair grafts to act as temporary scaffolds to support tendon healing. It has been estimated that thousands of extracellular matrix repair grafts are used annually to augment surgical repair of rotator cuff tears. The only mechanical assessment of the suitability of these grafts for rotator cuff repair has been made using tensile testing only, and compared grafts to canine infraspinatus. As the shoulder and rotator cuff tendons are exposed to shearing as well as uniaxial loading, we compared the response of repair grafts and human rotator cuff tendons to shearing mechanical stress. We used a novel technique to study material deformation, dynamic shear analysis (DSA). Methods. The shear properties of four RCT repair grafts were measured (Restore, GraftJacket, Zimmer Collagen Repair and SportsMesh). 3mm-sized biopsy samples were taken and subjected to DSA using oscillatory deformation under compression to calculate the storage modulus (G') as an indicator of mechanical integrity. To assess how well the repair grafts were matched to normal rotator cuff tendons, the storage modulus was calculated for 18 human rotator cuff specimens which were obtained from patients aged between 22 and 89 years (mean age 58.8 years, with 9 males and 9 females). Control human rotator cuff tendons were obtained from the edge of tendons during hemiarthoplasties and stabilisations. A 1-way ANOVA of all of the groups was performed to compare shear properties between the different commercially available repair grafts and human rotator cuff tendons to see if they were different. Specific comparison between the different repair grafts and normal rotator cuff tendons was done using a Dunn's multiple comparison test. Results. We report a significant difference in the shear moduli of all four rotator cuff repair grafts (P<0.0001, 1 way ANOVA, Kruskall-Wallis test). 2 of the grafts, Zimmer Collagen Repair and SportMesh, were not significantly different when compared to rotator cuff tendons and were found to have comparable shear mechanical properties (P > 0.05, Dunn's multiple comparison test). The other repair grafts, GraftJacket and Restore, had a significantly lower storage modulus when compared to human rotator cuff tendons. Conclusions. With increasing numbers of repairs of rotator cuff tears, and augmentation of these repairs, there is a need to understand the mechanical and biological properties of the both repair grafts and the tendons they are designed to augment. At present there is no clear definition of the ideal mechanobiological properties of rotator cuff repair patches. Current rotator cuff repair grafts display a wide variation in their shear mechanical properties, and how closely they are matched to the mechanical properties of human rotator cuff tendons. It is hoped that this study may help to guide surgeons in deciding on the most appropriate rotator cuff tendon repair graft


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 206 - 206
1 Mar 2010
Wallace A Kalogrianitis S
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Purpose of the study: To present our experience in managing Sterno-Clavicular Joint (SCJ) problems. SCJ pain is caused by a number of pathological conditions that include primary, post-infection, and post-traumatic OsteoArthritis (OA), Sterno-Costo-Clavicular Hyperotosis (SCCH) and posttraumatic instability. Methods: All cases of painful SCJ problems treated surgically by the senior author over the past 20 years have been reviewed. Results: All operations have been carried out using a “necklace” thyroid type incision. OA in which the pain becomes chronic and disabling, has been treated surgically. Medial clavicle reshaping (2), or hemiarthroplasty with a radial head prosthesis (3), sometimes combined with an interpositional arthroplasty using a GraftJacket is a new technique, developed to obliterate dead space, improve wound cosmesis, and prevent regeneration of the medial clavicle. SCCH is strongly associated with seronegative spondyloarthropathy, and can from part of the SAPHO syndrome (Synovitis, Acne, Pustulosis, Hyperostosis, and Osteitis), Patients with severe excruciating pain and those with restricted motion resulting from complete fusion of the clavicle and sternum may be candidates for surgical treatment. Excision of the medial end of the clavicle (1), the whole clavicle (1) and replacement hemiarthroplasty using a radial head as well as a pectoralis major flap interposition between the first rib and the clavicle (1), is a technique that has not been described previously. Instability for persistent subluxation or dislocation of the SCJ has been treated with interposition with Graft-Jacket +/− medial clavicle resection (2) or a sterno-mastoid tendon stabilisation (2). Conclusions: Previous surgical treatment of SCJ problems has been disappointing. Rockwood’s success rate with excision of the medial end of the clavicle alone has been poor (40% good only) – these newer techniques show greater promise