Exactech Shoulder Post Market Clinical Follow-up Study
Condition(s) studied
Study summary
The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.
Eligibility
Primary outcome measure(s)
- Constant — Through study completion, an average of 1 per year
Constant Shoulder Score - 100 points scale about pain, Activities of daily living, Strength test, and Range of Motions questions about shoulder where 100 % corresponds to the highest pain - ASES — Through study completion, an average of 1 per year
American Shoulder and Elbow Surgeons Score (ASES) - 100 points scale about shoulder pain and performance evaluation in activities of daily living where 100 indicates the best shoulder condition - Oxford Score (may be used as an optional form for surgeons in the United Kingdom) — Through study completion, an average of 1 per year
Oxford Shoulder Score (OSS) - 12 questions assessing outcomes of shoulder surgery and its impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems - Maximum score is 60 and indicates greater degree of disability - TESS (may be used as specific forms related to the pre-operative condition/diagnosis) — Through study completion, an average of 1 per year
Toronto Extremity Salvage Score (TESS) - Patient functional assessment following for surgery for musculoskeletal tumors (Humeral Reconstruction Stem only) - 100-point score where higher score indicates a better outcome - MSTS (may be used as specific forms related to the pre-operative condition/diagnosis) — Through study completion, an average of 1 per year
Musculoskeletal Tumor Society (MSTS) - 30 points \[6 times (range 0-5)\], simple measure of the upper extremity function (Humeral Reconstruction Stem only) - The maximum corresponds to the best score
Trial sites (40)
| Facility | City | Region | Status |
|---|---|---|---|
| South County Orthopedic Specialists | Laguna Woods | California | Recruiting |
| Stanford Health Care | Redwood City | California | Recruiting |
| Alpine Orthopaedic Medical Group | Stockton | California | Recruiting |
| Western Orthopaedics | Denver | Colorado | Recruiting |
| Orthopaedic and Spine Center of the Rockies | Fort Collins | Colorado | Recruiting |
| UF Health Orthopaedics and Sports Medicine Institute | Gainesville | Florida | Recruiting |
| Mayo Clinic | Jacksonville | Florida | Recruiting |
| Florida Atlantis Orthopedics | Palm Beach Gardens | Florida | Recruiting |
| Orthopaedic Medical Group of Tampa Bay | Tampa | Florida | Recruiting |
| HSS Florida | West Palm Beach | Florida | Recruiting |
| Orthopedic and Sports Medicine | Augusta | Georgia | Recruiting |
| OrthoIllinois | Rockford | Illinois | Recruiting |
| Barrington Orthpedic Specialists | Schaumburg | Illinois | Recruiting |
| Henry Ford Health | Detroit | Michigan | Recruiting |
| Hospital for Joint Diseases - NYU Langone Health | New York | New York | Recruiting |
| Lenox Health Greenwich Village | New York | New York | Recruiting |
| Southeastern Sports Medicine and Orthopedics | Asheville | North Carolina | Recruiting |
| Duke Department of Orthopedic Surgery | Durham | North Carolina | Recruiting |
| Crystal Clinic Orthopaedic | Akron | Ohio | Recruiting |
| Charleston Orthopaedic Associates | Charleston | South Carolina | Recruiting |
| Steadman Hawkins Clinic of the Carolinas | Greenville | South Carolina | Recruiting |
| Bone and Joint Institute of Tenessee | Franklin | Tennessee | Recruiting |
| Atlantic Orthopaedics Specialists | Virginia Beach | Virginia | Recruiting |
| Orthopaedic Associates of Wisconsin | Pewaukee | Wisconsin | Recruiting |
| St Joseph's Health Care | London | Ontario | Recruiting |
| Clinique Belledone | Grenoble | France | Recruiting |
| Centre de l'arthrose | Mérignac | France | Recruiting |
| Clinique Mutualiste La Sagesse | Rennes | France | Recruiting |
| Malteser Waldkrankenhaus Erlangen | Erlangen | Germany | Recruiting |
| Orthopadische Praxisklinik Von Vincke | Münster | Germany | Recruiting |
| Policlinico Morgagni | Catania | Italy | Recruiting |
| Campolongo Hospital | Eboli | Italy | Recruiting |
| Circle Health Group | Reading | Berks | Recruiting |
| Yeovil District Hospital NHS Foundation Trust | Yeovil | Summerset | Recruiting |
| The Sulis Hospital Bath | Bath | United Kingdom | Recruiting |
| Bedford Hospital | Bedford | United Kingdom | Recruiting |
| Ipswich Hospital | Ipswich | United Kingdom | Recruiting |
| Leicester General Hospital | Leicester | United Kingdom | Recruiting |
| University Hospital South Manchester | Manchester | United Kingdom | Recruiting |
| Nottingham University Hospital | Nottingham | United Kingdom | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05603728 on ClinicalTrials.gov ↗ ← All trials in the UK