Exactech Shoulder Post Market Clinical Follow-up Study

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes

Conditions
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Fracture, Osteo Arthritis Shoulders, Osteonecrosis, Rotator Cuff Tears, Rotator Cuff Tear Arthropathy, Ankylosing Spondylitis, Post-traumatic Osteoarthritis, Rheumatoid Arthritis, Infections

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |