An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Osteo Arthritis Shoulders
- Sponsor
- Exactech
- Enrollment
- 20000
- Locations
- 38
- Primary Endpoint
- Constant
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Constant
Time Frame: 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
TESS (may be used as specific forms related to the pre-operative condition/diagnosis)
Time Frame: 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)
Time Frame: 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
Oxford Score (may be used as an optional form for surgeons in the United Kingdom)
Time Frame: 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
ASES
Time Frame: 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