Rheumatoid Arthritis Clinical Trial
Official title:
An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes
NCT number | NCT05603728 |
Other study ID # | CR09-005 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 2010 |
Est. completion date | September 30, 2031 |
Verified date | February 2024 |
Source | Exactech |
Contact | Rachael Craig |
Phone | 352-377-1140 |
rachael.craig[@]exac.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 20000 |
Est. completion date | September 30, 2031 |
Est. primary completion date | December 31, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty) - Patient is at least 21 years of age - 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) |
Country | Name | City | State |
---|---|---|---|
France | Cite Sante | Cavaillon | |
France | Clinique Chenieux | Limoges | |
France | Centre de l'arthrose | Mérignac | |
France | Clinique Mutualiste La Sagesse | Rennes | |
Italy | Policlinico Morgagni | Catania | |
Italy | Campolongo Hospital | Eboli | |
United Kingdom | The Sulis Hospital Bath | Bath | |
United Kingdom | Gloucester Royal Hospital Foundation Trust | Gloucester | |
United Kingdom | Ipswich Hospital | Ipswich | |
United Kingdom | University Hospital South Manchester | Manchester | |
United Kingdom | Nottingham University Hospital | Nottingham | |
United Kingdom | Circle Health Group | Reading | Berks |
United Kingdom | Yeovil District Hospital NHS Foundation Trust | Yeovil | Summerset |
United States | Crystal Clinic Orthopaedic | Akron | Ohio |
United States | Southeastern Sports Medicine and Orthopedics | Asheville | North Carolina |
United States | Orthopedic and Sports Medicine | Augusta | Georgia |
United States | Charleston Orthopaedic Associates | Charleston | South Carolina |
United States | Western Orthopaedics | Denver | Colorado |
United States | Henry Ford Health | Detroit | Michigan |
United States | Orthopaedic and Spine Center of the Rockies | Fort Collins | Colorado |
United States | Bone and Joint Institute of Tenessee | Franklin | Tennessee |
United States | UF Health Orthopaedics and Sports Medicine Institute | Gainesville | Florida |
United States | Steadman Hawkins Clinic of the Carolinas | Greenville | South Carolina |
United States | Mayo Clinic | Jacksonville | Florida |
United States | South County Orthopedic Specialists | Laguna Woods | California |
United States | Hospital for Joint Diseases - NYU Langone Health | New York | New York |
United States | Lenox Health Greenwich Village | New York | New York |
United States | Florida Atlantis Orthopedics | Palm Beach Gardens | Florida |
United States | Palm Beach Orthopaedic Institute | Palm Beach Gardens | Florida |
United States | Orthopaedic Associates of Wisconsin | Pewaukee | Wisconsin |
United States | Stanford Health Care | Redwood City | California |
United States | OrthoIllinois | Rockford | Illinois |
United States | Orthopaedic Medical Group of Tampa Bay | Tampa | Florida |
United States | Atlantic Orthopaedics Specialists | Virginia Beach | Virginia |
Lead Sponsor | Collaborator |
---|---|
Exactech |
United States, France, Italy, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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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