Active Bones, Joints & Muscles NIHR-supported project Digestion, Kidneys & Other Organs

Exactech An Open Label, Multi-Centre, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes. CR09-005 Exactech

In plain English

AI plain-English summary

Thousands of patients each year receive an Equinoxe shoulder replacement implant, but no one has systematically tracked what happens to those joints over a full decade. This study addresses a straightforward gap in medical knowledge. Shoulder replacements are common and effective in the short term, but surgeons and regulators lack robust long-term data on how these implants perform after five or ten years. The implants are already licensed and in use across European markets; the question is whether they continue to function safely and reliably as patients age. Without this information, clinicians cannot give patients accurate advice about what to expect years after surgery, and regulators cannot confirm that the devices meet long-term safety standards. If the research succeeds, it will provide concrete evidence on implant survival rates, complication patterns, and how well the artificial joints maintain pain relief and shoulder function over time. This could directly change how surgeons counsel patients before surgery, how hospitals choose implants, and how manufacturers refine future designs. It may also inform regulatory decisions about post-market surveillance requirements for similar orthopaedic devices. The project is not fundamental science. It is a practical, observational follow-up study designed to answer a specific clinical question: do these shoulder replacements hold up for a decade?

View original technical description
This study is a post-market clinical follow up of the Equinoxe shoulder arthroplasty system which aims to treat the shoulder by offering pain relief and restoration of joint functionality. The Equinoxe implants are licensed for use and currently CER markets. The purpose of this study is to collect and evaluate long-term clinical and radiographic safety and performance outcomes following shoulder arthroplasty in order to better understand the safety, effectiveness, performance, and implant survival of shoulder arthroplasty over time (up to 10 years).

Researchers

Ben Gooding (Principal Investigator)

Related Research

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HIPSTER – HIP Surgical Techniques to Enhance Rehabilitation
Study of Retrieved Orthopaedic Implants and Associated Tissues and Data
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Original classification

Musculoskeletal, Surgery, Inflammation and Recovery

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.