1st EFORT European Consensus: Medical & Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices

Innovations in Orthopaedics and Traumatology have contributed to the achievement of a high-quality level of care in musculoskeletal disorders and injuries over the past decades. The applications of new implants as well as diagnostic and therapeutic techniques in addition to implementation of clinical research, have significantly improved patient outcomes, reduced complication rates and length of hospital stay in many areas. However, the regulatory framework is extensive, and there is a lack of understanding and clarity in daily practice what the meaning of clinical & pre‐clinical evidence as required by the MDR is. Thus, understanding and clarity are of utmost importance for introduction of new implants and implant-related instrumentation in combination with surgical technique to ensure a safe use of implants and treatment of patients. Therefore EFORT launched IPSI, The Implant and Patient Safety Initiative, which starting from an inaugural workshop in 2021 issued a set of recommendations, notably through a subsequent Delphi Process involving the National Member Societies of EFORT, European Specialty Societies as well as International Experts. These recommendations provide surgeons, researchers, implant manufacturers as well as patients and health authorities with a consensus of the development, implementation, and dissemination of innovation in the field of arthroplasty. The intended key outcomes of this 1st EFORT European Consensus on “Medical & Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices”are consented, practical pathways to maintain innovation and optimisation of orthopaedic products and workflows within the boundaries of MDR 2017/745. Open Access practical guidelines based on adequate, state of the art pre-clinical and clinical evaluation methodologies for the introduction of joint replacements and implant-related instrumentation shall provide hands-on orientation for orthopaedic surgeons, research institutes and laboratories, orthopaedic device manufacturers, Notified Bodies but also for National Institutes and authorities, patient representatives and further stakeholders. We would like to acknowledge and thank the Scientific Committee members, all International Expert Delegates, the Delegates from European National & Specialty Societies and the Editorial Team for their outstanding contributions and support during this EFORT European Consensus

Use of synthetic health data in prototyping for developing dental implant registry services

Developing novel applications in healthcare and dentistry can be challenging due to lack of application requirements, uncertain stakeholders, and no available test data. Such conditions exist in tooth implant dentistry, where innovative services are needed to record and communicate data. This study investigates how manually generated synthetic data can support the development and demonstration of new services for a dental implant registry. Furthermore, other objectives are to evaluate the usefulness of the developed services and to determine whether the development process has contributed to improving the data model used by a dental implant register. To answer these objectives, we have through the use of design science methodology developed a high-fidelity dashboard prototype and a synthetic dataset in parallel. The development process was carried out in iterations, involving stakeholders as early as possible. The results indicate that the use of synthetic data to demonstrate possible future services was an essential component of the development process, facilitating early active participation of stakeholders. In particular, data with some realistic qualities were the most valuable in this process. Furthermore, the development process we used resulted in some contributions to the registry's data model, but fewer than expected. In summary, the services we developed were deemed useful by stakeholders. These results suggest that synthetic data generated manually, together with a high-fidelity prototype, may contribute to involving stakeholders early in the development process. This participation may ease the process of identifying application requirements and engaging stakeholders, potentially producing useful features.Masteroppgave i Programutvikling samarbeid med HVLPROG399MAMN-PRO

How long does a shoulder replacement last? A systematic review and meta-analysis of case series and national registry reports with more than 10 years of follow-up

This is the author accepted manuscript. The final version is available from Elsevier via the DOI in this recordBackground: Shoulder replacement is an increasingly common treatment for end-stage degenerative shoulder conditions. Some shoulder replacements are unsuccessful and additional operations might be required. It is important for patients and clinicians to know how long shoulder replacements last and how effectively they reduce pain and improve function. This study aims to determine the longevity and long-term efficacy of shoulder replacements. Methods: In this systematic review and meta-analysis, we searched MEDLINE and Embase from their inception to Sept 24, 2019, for case series and registry data reporting 10-year or longer survival of total shoulder replacements, humeral hemiarthroplasties, and reverse total shoulder replacements of a specific brand of implant. Survival, implant, and patient-reported outcome measures data were extracted. The primary outcome was implant survival. We reviewed and analysed national joint replacement registries separately. We weighted each series by SE and calculated a pooled survival estimate at years 10, 15, and 20. For patient-reported outcome measures we pooled the standardised mean difference at 10 years. This study is registered with PROSPERO, CRD42019140221. Findings: 927 non-duplicate articles were identified by our search, nine articles (reporting ten series) were eligible for analysis of survival and six articles were eligible for analysis of patient reported outcomes. The ten series reported all-cause survival of 529 total shoulder replacements and 364 humeral hemiarthroplasties; no series for reverse total shoulder replacement met the inclusion criteria. The estimated 10-year survival for total shoulder replacement was 94·6% (95% CI 93·6–97·6) and humeral hemiarthroplasties was 90·4% (87·0–94·0). A single registry contributed 7651 total shoulder replacements, 1395 humeral hemiarthroplasties, and 7953 reverse total shoulder replacements. The pooled registry 10-year survival was 92·0% (95% CI 91·0–93·0) for total shoulder replacement, 85·5% (83·3–87·7) for humeral hemiarthroplasties, and 94·4% (93·4–95·7) for patients with osteoarthritis who had reverse total shoulder replacement and 93·6% (91·1–95·8) for patients with rotator cuff arthropathy who had reverse total shoulder replacement. Pooled 10-year patient-reported outcome measures showed a substantial improvement from baseline scores, with a standardised mean difference of 2·13 (95% CI 1·93–2·34). Interpretation: Our data show that approximately 90% of shoulder replacements last for longer than 10 years and patient-reported benefits are sustained. Our findings will be of use to surgeons and patients in the informed consent process and to health-care providers for resource planning. Funding: The National Institute for Health Research, the National Joint Registry for England, Wales, Northern Ireland, and Isle of Man, and the Royal College of Surgeons of England.National Institute for Health Research (NIHR)National Joint Registry for England, Wales, Northern Ireland, and Isle of ManRoyal College of Surgeons of Englan

The PATH study: Preparing for the Adoption of innovative hearing THerapies

BACKGROUND: Innovative drug, gene and cell therapies are being developed to address the unmet clinical need of people with hearing loss. With approval for clinical use on the horizon in the next 5 years, it is essential to start preparing for the implementation of these therapies in hearing healthcare services. AIM: To provide stakeholders who develop, will use and pay for innovative hearing therapies, with a detailed understanding of the elements that influence their adoption and implementation and with practical strategies to facilitate their uptake in the UK healthcare system. METHOD: 1) To inform product development and decisions on value for money, I constructed an early health economic model with input data from literature searches and 26 interviews. 2) To characterise and understand the elements that influence the adoption and implementation of innovative hearing therapies in the UK healthcare system, I conducted 37 semi-structured interviews drawing upon insights from the early health economic model. 3) To add to this understanding, I performed a hermeneutic review of elements that influence the adoption and implementation of innovative therapies in general. 4) To integrate the findings from my thesis, I constructed a framework that maps the elements that influence innovative hearing therapy adoption and implementation, and that summarises practical strategies to facilitate uptake. RESULTS: I found that alliances between clinicians, scientists, patients, biotechnology and hearing technology companies can facilitate adoption of innovative hearing therapies, benefitting from pooled resources, diffusion networks and established market access. Timely clinician education can break down engrained clinical practices and gain clinician buy-in. Early engagement with patients can help ensure these therapies meet patient needs and generate patient and public interest, which can influence clinician uptake and policy decisions. Precision diagnostics are critical to the development and uptake of innovative hearing therapies; co-development strategies and novel regulatory pathways can accelerate their development. Accelerator organisations can help navigate healthcare systems, assist with manufacturing and distribution strategies, support clinical trialing, help develop business cases, and lobby decision makers. Additional insights revealed that novel payment strategies and robust business cases can help make procurement affordable and avoid delays in adoption. Real world data can increase confidence to take-up innovative hearing therapies, support payment strategies, early access programs and help fulfil regulatory requirements. CONCLUSION: My research has resulted in a framework that can accelerate the uptake of innovative hearing therapies across healthcare systems. Stakeholders can use my framework to gain detailed information on the processes that need to take place for adoption and implementation of these therapies as well as strategies to facilitate these processes

Clinical, industrial, and research perspectives on powder bed fusion additively manufactured metal implants

For over ten years, metallic skeletal endoprostheses have been produced in select cases by additive manufacturing (AM) and increasing awareness is driving demand for wider access to the technology. This review brings together key stakeholder perspectives on the translation of AM research; clinical application, ongoing research in the field of powder bed fusion, and the current regulatory framework. The current clinical use of AM is assessed, both on a mass-manufactured scale and bespoke application for patient specific implants. To illuminate the benefits to clinicians, a case study on the provision of custom cranioplasty is provided based on prosthetist testimony. Current progress in research is discussed, with immediate gains to be made through increased design freedom described at both meso- and macro-scale, as well as long-term goals in alloy development including bioactive materials. In all cases, focus is given to specific clinical challenges such as stress shielding and osseointegration. Outstanding challenges in industrialisation of AM are openly raised, with possible solutions assessed. Finally, overarching context is given with a review of the regulatory framework involved in translating AM implants, with particular emphasis placed on customisation within an orthopaedic remit. A viable future for AM of metal implants is presented, and it is suggested that continuing collaboration between all stakeholders will enable acceleration of the translation process

Knee replacement revision: an international comparison

AbstractBackground and purpose: The need for knee replacement revision arises from a combination of patient, prosthesis and surgeon factors. Registry data can help study these relationships. Pooling data from multiple registries may increase both reliability and generalizability. The study aim was to gain a multi-national overview of knee replacement revision, to inform best-practice and improve outcomes.Patients and methods: Data was obtained from the Swedish Knee Arthroplasty Register (SKAR), the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR), and the Kaiser Permanente Joint Replacement Registry (KPJRR) from the US. Procedure numbers, demographic characteristics, prosthesis factors, revision diagnoses and revision procedure information were used. Equivalent diagnosis groups were created to allow analysis. Similarities and differences between registries were determined, as were time-related trends, and meta-analytic techniques were used to estimate the influence of patient or prosthesis factors on revision. More detailed study of revision for instability was carried out.Results: Primary knee replacement incidence had increased and revision procedures too, but by a smaller amount. Most common reasons for revision were infection, loosening and instability. Revision for infection had increased. Practice variations were seen between registries, particularly with prosthesis constraint and patella component usage, and also over time, with bearing mobility and polyethylene type. All-cause revision rates were higher with posterior stabilized, cementless and mobile-bearing components. Posterior stabilized prostheses had increased revision for infection, fracture and loosening, mobile-bearing components had increased revision for arthrofibrosis, instability and patella reasons, cementless fixation revisions for wear and procedures where patella components were not used had increased revision for patella reasons. Further prosthesis factors related to revision for instability were non-cruciate retaining components and inserts made of non-cross-linked polyethylene and those >14mm thick. Insert exchange was the most common revision procedure, but fewer 2nd revisions were seen with a major revision using more constrained implants.Interpretation: Practice variation can partially explain between-registry differences in incidence, and variability in reasons for revision. Understanding interactions between prosthesis factors and revision can help inform prosthesis choices. Use of lower risk prostheses can improve all-cause revision, revision for specific reasons, and additionally, revision and 2nd revision for instability