An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes
| Registry | NCT05603728 |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 20000 (Estimated) |
| Sponsor | Exactech (Industry) |
| Conditions | Osteo Arthritis Shoulders, Osteonecrosis, Rotator Cuff Tears, Rotator Cuff Tear Arthropathy, Ankylosing Spondylitis, Post-traumatic Osteoarthritis, Rheumatoid Arthritis, Fracture, Infections |
| Dates | start 2007-07-19, primary completion 2030-12-31 (estimated), completion 2031-12-31 (estimated), first posted 2022-11-03, last updated 2026-09-17 |
| Locations | 40 sites in United States, Canada, France, Germany, Italy, United Kingdom |
Related Papers Related Patents Related Grants Related Experts
All trials for Osteo Arthritis Shoulders All trials for Osteonecrosis
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.
Sex: All, ages: 21 Years to any
Inclusion Criteria: * Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty) * Patient is skeletelly mature * Patient is expected to survive at least 2 years beyond surgery * Patient is willing to participate by complying with pre- and postoperative visit requirements * Patient is willing and able to read and sign a study informed consent form Exclusion Criteria: * Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implantation should be delayed until infection is resolved * Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis * Medial humeral bone loss resulting in compromised humeral stem fixation * Proximal humeral bone loss extending distal to the surgical neck where there is compromised humeral stem fixation * Neuromuscular disorders that do not allow control of the joint * Significant injury to the brachial plexus * Non-functional deltoid muscles * Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system * The patient is unwilling or unable to comply with the post-operative care instructions * Alcohol, drug, or other subtance abuse * Any disease state that could adversaly affect the function or longevity of the implant * Patient is pregnant * Patient is a prisoner * Patient is contraindicated for the surgery * Revision cases in which a stemmed humeral component was used (Stemless Shoulder System) * Metal allergy or sensitivity to the implants materials (Stemless Shoulder System) * Acute fracture of the proximal humerus and displacement of the tuberosities, displaced three or four part fractures of the proximal humerus (hemi-arthroplasty), or acture fracture of the proximal humerus with failure of the glenohumeral joint (total anatomic shoulder arthroplasty) (Stemless Shoulder System) * Acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty) (Stemless Shoulder System)
| Facility | City | Country | Status |
|---|---|---|---|
| South County Orthopedic Specialists | Laguna Woods, California | United States | Recruiting |
| Stanford Health Care | Redwood City, California | United States | Recruiting |
| Alpine Orthopaedic Medical Group | Stockton, California | United States | Recruiting |
| Western Orthopaedics | Denver, Colorado | United States | Recruiting |
| Orthopaedic and Spine Center of the Rockies | Fort Collins, Colorado | United States | Recruiting |
| UF Health Orthopaedics and Sports Medicine Institute | Gainesville, Florida | United States | Recruiting |
| Mayo Clinic | Jacksonville, Florida | United States | Recruiting |
| Florida Atlantis Orthopedics | Palm Beach Gardens, Florida | United States | Recruiting |
| Orthopaedic Medical Group of Tampa Bay | Tampa, Florida | United States | Recruiting |
| HSS Florida | West Palm Beach, Florida | United States | Recruiting |
| Orthopedic and Sports Medicine | Augusta, Georgia | United States | Recruiting |
| OrthoIllinois | Rockford, Illinois | United States | Recruiting |
| Barrington Orthpedic Specialists | Schaumburg, Illinois | United States | Recruiting |
| Henry Ford Health | Detroit, Michigan | United States | Recruiting |
| Hospital for Joint Diseases - NYU Langone Health | New York, New York | United States | Recruiting |
| Lenox Health Greenwich Village | New York, New York | United States | Recruiting |
| Southeastern Sports Medicine and Orthopedics | Asheville, North Carolina | United States | Recruiting |
| Duke Department of Orthopedic Surgery | Durham, North Carolina | United States | Recruiting |
| Crystal Clinic Orthopaedic | Akron, Ohio | United States | Recruiting |
| Charleston Orthopaedic Associates | Charleston, South Carolina | United States | Recruiting |
| Steadman Hawkins Clinic of the Carolinas | Greenville, South Carolina | United States | Recruiting |
| Bone and Joint Institute of Tenessee | Franklin, Tennessee | United States | Recruiting |
| Atlantic Orthopaedics Specialists | Virginia Beach, Virginia | United States | Recruiting |
| Orthopaedic Associates of Wisconsin | Pewaukee, Wisconsin | United States | Recruiting |
| St Joseph's Health Care | London, Ontario | Canada | 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 | United Kingdom | Recruiting |
| Yeovil District Hospital NHS Foundation Trust | Yeovil, Summerset | United Kingdom | 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 |