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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Constant | 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 | Through study completion, an average of 1 per year |
| ASES | 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 | Through study completion, an average of 1 per year |
| Oxford Score (may be used as an optional form for surgeons in the United Kingdom) | 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 | Through study completion, an average of 1 per year |
| TESS (may be used as specific forms related to the pre-operative condition/diagnosis) | 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 | Through study completion, an average of 1 per year |
| MSTS (may be used as specific forms related to the pre-operative condition/diagnosis) | 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 | Through study completion, an average of 1 per year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachael Craig | Contact | 352-377-1140 | rachael.craig@exac.com | |
| Sandrine Angibaud | Contact | 352-377-1140 | sandrine.angibaud@exac.com |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Wright, MD | UF Health Orthopaedics and Sports Medicine Institute | Principal Investigator |
| Young Kwon, MD | Hospital for Joint Diseases - NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South County Orthopedic Specialists | Recruiting | Laguna Woods | California | 92637 | United States |
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| Richard Friedman, MD |
| Charleston Orthopaedic Associates |
| Principal Investigator |
| Richard Jones, MD | Southeastern Orthopedics and Spine | Principal Investigator |
| Howard Routman, DO | Florida Atlantis Orthopaedics | Principal Investigator |
| Ryan Simovitch, MD | Palm Beach Orthopaedic Institute | Principal Investigator |
| Geoffrey Abrams, MD | Stanford Health Care | Principal Investigator |
| Pierre Henri Flurin, MD | Centre de l'Arthrose | Principal Investigator |
| Yann Marczuk, MD | Clinique Chenieux | Principal Investigator |
| Harry Brownlow, MD | Circle Health Group | Principal Investigator |
| Oliver Donaldson, MD | Yeovil District Hospital NHS Foundation | Principal Investigator |
| Chris Roberts, MD | Ipswich Hospital | Principal Investigator |
| Chris Peach, MD | University Hospital South Manchester | Principal Investigator |
| Angelo Di Giunta, MD | Policlinico Morgagni | Principal Investigator |
| Alfonso Romano, MD | Campolongo Hospital | Principal Investigator |
| Sean Grey, MD | Orthopaedic and Spine Center of the Rockies | Principal Investigator |
| Chad Manke, MD | Altantic Orthopaedics Specialists | Principal Investigator |
| Rick Papandrea, MD | Orthopaedic Associates of Wisconsin | Principal Investigator |
| Andrew Chambler, MD | The Sulis Hospital Bath | Principal Investigator |
| Curt Noel, MD | Crystal Clinic Orthopaedic | Principal Investigator |
| Stephen Parada, MD | Orthopedic and Sports Medicine | Principal Investigator |
| Ari Youderian, MD | South County Orthopedic Specialists | Principal Investigator |
| Ian Byram, MD | Bone and Joint Institute of Tennessee | Principal Investigator |
| Tewfik Benkalfate, MD | Clinique Mutualiste la Sagesse | Principal Investigator |
| Peter McCann, MD | Lenox Health Greenwich Village | Principal Investigator |
| Stephanie Muh, MD | Henry Ford Health | Principal Investigator |
| Bradley Schoch, MD | Mayo Clinic | Principal Investigator |
| Stephan Pill, MD | Steadman Hawkins Clinic of the Carolinas | Principal Investigator |
| Scott Trenhaile, MD | OrthoIllinois | Principal Investigator |
| Bryan Butler, MD | Orthopaedic Medical Group of Tampa Bay | Principal Investigator |
| Ben Gooding, MD | Nottingham City Hospital | Principal Investigator |
| Brad Carofino, MD | Altantic Orthopaedics Specialist | Principal Investigator |
| Ben Sears, MD | Western Orthopaedics | Principal Investigator |
| Kenneth Faber, MD | St Joseph's Health Care | Principal Investigator |
| Jaicharan Iyengar, MD | Alpine Orthopaedic Medical Group | Principal Investigator |
| Oke Anakwenze, MD | Duke Department of Orthopedic Surgery | Principal Investigator |
| Thomas Obermeyer, MD | Barrington Orthopedic | Principal Investigator |
| Alison Armstrong, MD | Leicester General Hospital | Principal Investigator |
| George Malal, MD | Bedford Hospital | Principal Investigator |
| Stanford Health Care | Recruiting | Redwood City | California | 94063 | United States |
|
| Alpine Orthopaedic Medical Group | Recruiting | Stockton | California | 95204-5508 | United States |
| Western Orthopaedics | Recruiting | Denver | Colorado | 80218 | United States |
|
| Orthopaedic and Spine Center of the Rockies | Recruiting | Fort Collins | Colorado | 80525 | United States |
|
| UF Health Orthopaedics and Sports Medicine Institute | Recruiting | Gainesville | Florida | 32607 | United States |
|
| Mayo Clinic | Recruiting | Jacksonville | Florida | 32224 | United States |
|
| Palm Beach Orthopaedic Institute | Recruiting | Palm Beach Gardens | Florida | 33401 | United States |
|
| Florida Atlantis Orthopedics | Recruiting | Palm Beach Gardens | Florida | 33410 | United States |
|
| Orthopaedic Medical Group of Tampa Bay | Recruiting | Tampa | Florida | 33619 | United States |
|
| Orthopedic and Sports Medicine | Recruiting | Augusta | Georgia | 30909 | United States |
|
| OrthoIllinois | Recruiting | Rockford | Illinois | 61107 | United States |
|
| Barrington Orthpedic Specialists | Recruiting | Schaumburg | Illinois | 60195 | United States |
| Henry Ford Health | Recruiting | Detroit | Michigan | 48067 | United States |
|
| Hospital for Joint Diseases - NYU Langone Health | Recruiting | New York | New York | 10003 | United States |
|
| Lenox Health Greenwich Village | Recruiting | New York | New York | 10011 | United States |
|
| Southeastern Sports Medicine and Orthopedics | Recruiting | Asheville | North Carolina | 28803 | United States |
|
| Duke Department of Orthopedic Surgery | Recruiting | Durham | North Carolina | 27705 | United States |
| Crystal Clinic Orthopaedic | Recruiting | Akron | Ohio | 44333 | United States |
|
| Charleston Orthopaedic Associates | Recruiting | Charleston | South Carolina | 29414 | United States |
|
| Steadman Hawkins Clinic of the Carolinas | Recruiting | Greenville | South Carolina | 29615 | United States |
|
| Bone and Joint Institute of Tenessee | Recruiting | Franklin | Tennessee | 37067 | United States |
|
| Atlantic Orthopaedics Specialists | Recruiting | Virginia Beach | Virginia | 23320 | United States |
|
| Orthopaedic Associates of Wisconsin | Recruiting | Pewaukee | Wisconsin | 53072 | United States |
|
| St Joseph's Health Care | Recruiting | London | Ontario | N6A 4V2 | Canada |
| Clinique Chenieux | Recruiting | Limoges | 87039 | France |
|
| Centre de l'arthrose | Recruiting | Mérignac | 33700 | France |
|
| Clinique Mutualiste La Sagesse | Recruiting | Rennes | 35043 | France |
|
| Policlinico Morgagni | Recruiting | Catania | 95125 | Italy |
|
| Campolongo Hospital | Recruiting | Eboli | 84025 | Italy |
|
| Circle Health Group | Recruiting | Reading | Berks | RG2 7AU | United Kingdom |
|
| Yeovil District Hospital NHS Foundation Trust | Recruiting | Yeovil | Summerset | BA21 4AT | United Kingdom |
|
| The Sulis Hospital Bath | Recruiting | Bath | BA2 8SQ | United Kingdom |
|
| Bedford Hospital | Recruiting | Bedford | MK42 9DJ | United Kingdom |
| Ipswich Hospital | Recruiting | Ipswich | IP4 5PD | United Kingdom |
|
| Leicester General Hospital | Recruiting | Leicester | LE5 4PW | United Kingdom |
| University Hospital South Manchester | Recruiting | Manchester | M23 9LT | United Kingdom |
|
| Nottingham University Hospital | Recruiting | Nottingham | United Kingdom |
|
| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| D000070636 | Rotator Cuff Injuries |
| D000070656 | Rotator Cuff Tear Arthropathy |
| D013167 | Spondylitis, Ankylosing |
| D001172 | Arthritis, Rheumatoid |
| D050723 | Fractures, Bone |
| D007239 | Infections |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
| D002805 | Chondrocalcinosis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D000070657 | Crystal Arthropathies |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D000844 | Ankylosis |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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