Introduction Despite multiple scandals in the medical implant sector, premarket testing has been the attention of little published research. Complications related to new devices, such as the DePuy Articular Surface Replacement (ASR, DePuy Synthes, USA), have raised the issue of how designs are tested and whether engineering standards remain up to date with our understanding of implant biomechanics. Despite much work setting up national joint registries to improve implant monitoring, there have been few academic studies examining the premarket engineering standards new implants must meet. Emerging global economies mean that the markets have changed, and it is unknown to what degree engineering standards vary around the world. Governments, industry and independent regulatory bodies all produce engineering standards; therefore, the comparison of surgical implants across different manufacturers and jurisdictions is difficult. In this review, we will systematically collate and compare engineering standards for trauma and orthopaedic implants around the world. This will help inform patient, hospital and surgeon choice and provide an evidence base for future research in this area. Methods and analysis This protocol is based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) guidelines. We will conduct a systematic review of trauma and orthopaedic engineering standards from four main sources of information as identified in our preliminary scoping searches: governments, industry, independent regulatory bodies and engineering and medical publications. Any current standard relevant to trauma and orthopaedic implants will be included. We will use a predefined search strategy and follow the recommendations of the Cochrane handbook where applicable. We will undertake a narrative synthesis with qualitative evaluation of homogeneity between engineering standards. Ethics and dissemination No ethics approval is required as no primary data are being collected. The results will be made available by peer-reviewed publication and reported according to PRISMA-P guidelines.

BACKGROUND:The success of rotator cuff repair is primarily dependent on tendon-bone healing. Failure is common because weak scar tissue replaces the native enthesis, rendering it prone to reruptures. A demineralized bone matrix (DBM) consists of a network of collagen fibers that provide a sustained release of growth factors such as bone morphogenetic proteins. Previous studies have demonstrated that it can regenerate a fibrocartilaginous enthesis.HYPOTHESIS:The use of a DBM and mesenchymal stem cells (MSCs) at the healing enthesis will result in a higher bone mineral density at the tendon insertion and will enhance the regeneration of a morphologically superior enthesis when compared with an acellular human dermal matrix.STUDY DESIGN:Controlled laboratory study.METHODS:Eighteen female Wistar rats underwent unilateral detachment of the supraspinatus tendon. Three weeks later, tendon repair was carried out in animals randomized into 3 groups: group 1 received augmentation of the repair with a cortical allogenic DBM (n = 6); group 2 received augmentation with a nonmeshed, ultrathick, acellular human dermal matrix (n = 6); and group 3 underwent tendon-bone repair without a scaffold (n = 6). All animals received 1 × 106 MSCs delivered in fibrin glue to the repair site. Specimens were retrieved at 6 weeks postoperatively for histological analysis and the evaluation of bone mineral density.RESULTS:All groups demonstrated closure of the tendon-bone gap with a fibrocartilaginous enthesis. Although there were no significant differences in the enthesis maturation and modified Movin scores, repair augmented with a dermal matrix + MSCs exhibited a disorganized enthesis, abnormal collagen fiber arrangement, and greater cellularity compared with other MSC groups. Only repairs augmented with a DBM + MSCs reached a bone mineral density not significantly lower than nonoperated controls.CONCLUSION:A DBM enhanced with MSCs can augment rotator cuff healing at 6 weeks and restore bone mineral density at the enthesis to its preinjury levels.CLINICAL RELEVANCE:Biological augmentation of rotator cuff repair with a DBM and MSCs may reduce the incidence of retears, although further studies are required to determine its effectiveness.

Introduction Despite multiple scandals in the medical implant sector, premarket testing has been the attention of little published research. Complications related to new devices, such as the DePuy Articular Surface Replacement (ASR, DePuy Synthes, USA), have raised the issue of how designs are tested and whether engineering standards remain up to date with our understanding of implant biomechanics. Despite much work setting up national joint registries to improve implant monitoring, there have been few academic studies examining the premarket engineering standards new implants must meet. Emerging global economies mean that the markets have changed, and it is unknown to what degree engineering standards vary around the world. Governments, industry and independent regulatory bodies all produce engineering standards; therefore, the comparison of surgical implants across different manufacturers and jurisdictions is difficult. In this review, we will systematically collate and compare engineering standards for trauma and orthopaedic implants around the world. This will help inform patient, hospital and surgeon choice and provide an evidence base for future research in this area. Methods and analysis This protocol is based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) guidelines. We will conduct a systematic review of trauma and orthopaedic engineering standards from four main sources of information as identified in our preliminary scoping searches: governments, industry, independent regulatory bodies and engineering and medical publications. Any current standard relevant to trauma and orthopaedic implants will be included. We will use a predefined search strategy and follow the recommendations of the Cochrane handbook where applicable. We will undertake a narrative synthesis with qualitative evaluation of homogeneity between engineering standards. Ethics and dissemination No ethics approval is required as no primary data are being collected. The results will be made available by peer-reviewed publication and reported according to PRISMA-P guidelines.

BACKGROUND:The purpose of this study was to assess the effect of demineralized bone matrix (DBM) on rotator cuff tendon-bone healing. The hypothesis was that compared with a commercially available dermal matrix scaffold, DBM would result in a higher bone mineral density and regenerate a morphologically superior enthesis in a rat model of chronic rotator cuff degeneration. METHODS:Eighteen female Wistar rats underwent unilateral detachment of the supraspinatus tendon. Three weeks later, tendon repair was carried out in animals randomized into 3 groups: group 1 animals were repaired with DBM (n = 6); group 2 received augmentation with the dermal scaffold (n = 6); and group 3 (controls) underwent nonaugmented tendon-bone repair (n = 6). Specimens were retrieved at 6 weeks postoperatively for histologic analysis and evaluation of bone mineral density. RESULTS:No failures of tendon-bone healing were noted throughout the study. All groups demonstrated closure of the tendon-bone gap with a fibrocartilaginous interface. Dermal collagen specimens exhibited a disorganized structure with significantly more abnormal collagen fiber arrangement and cellularity than in the DBM-based repairs. Nonaugmented repairs exhibited a significantly higher bone mineral density than in DBM and the dermal collagen specimens and were not significantly different from control limbs that were not operated on. CONCLUSION:The application of DBM to a rat model of chronic rotator cuff degeneration did not improve the composition of the healing enthesis compared with nonaugmented controls and a commercially available scaffold. However, perhaps the most important finding of this study was that the control group demonstrated a similar outcome to augmented repairs.

Purpose: The purpose of this study was to determine if demineralised bone matrix (DBM) enhanced with mesenchymal stem cells (MSCs) could improve healing when applied to a degenerative rotator cuff tear model.Methods: Eighteen female Wistar rats underwent unilateral detachment of the supraspinatus tendon.Three weeks later, tendon repair was carried out in animals randomized into three groups: Group 1 received augmentation of the repair with cortical allogenic DBM (n ¼ 6); Group 2 received augmentation with a commercially-available non-meshed, ultra-thick accellular human dermal matrix (n ¼ 6); and Group 3 underwent tendon-bone repair without a scaffold (n ¼ 6).All animals received one million MSCs.Specimens were retrieved at six weeks postoperatively for histological analysis and evaluation of bone mineral density.Results: All groups demonstrated closure of the tendon-bone gap with a fibrocartilaginous enthesis, but the degenerative process could not be reversed.Although there were no significant differences in the enthesis maturation and Modified Movin scores, repairs augmented with dermal matrix þ MSCs exhibited a disorganised enthesis, abnormal collagen fibre arrangement, and greater cellularity compared to other MSC groups.Only repairs augmented with DBM þ MSCs reached a bone mineral density not significantly lower than non-operated controls.Conclusions: This study demonstrated that when DBM and MSCs were applied to the healing enthesis in a chronic rotator cuff tear model, a fibrocartilaginous-based structure was produced, which significantly increased bone density compared to other groups.

BACKGROUND:To evaluate biological strategies that enhance tendon-bone healing in humans, it is imperative that suitable animal models accurately reproduce the pathological changes observed in the clinical setting following a tear. The purpose of the present study was to investigate rotator cuff degeneration in a rat, as well as assess the development of osteopenia at the enthesis following tendon detachment.METHODS:Eighteen female Wistar rats underwent unilateral detachment of the supraspinatus tendon. Specimens were retrieved at 4 weeks (n = 6), 6 weeks (n = 6) and 9 weeks (n = 6) postoperatively for histological analysis and peripheral quantitative computer tomography.RESULTS:Three weeks following tendon detachment, there was a significant increase in the modified Movin score, characterized by a loss of muscle mass, fatty infiltration, an increase in musculotendinous cellularity, loss of normal collagen fibre structure/arrangement, rounded tenocyte nuclei and an increase in the number of vascular bundles. This was accompanied by a reduction in bone mineral density at the tendon insertion site. After 3 weeks however, these changes were less prominent.CONCLUSIONS:The rotator cuff tendon-muscle-bone unit in a rat model 3 weeks after detachment of supraspinatus represents a valid model for investigating rotator cuff degeneration.