Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
- Conditions
- Rheumatoid ArthritisOncologyOsteoarthritis Shoulder
- Registration Number
- NCT05615246
- Lead Sponsor
- Exactech
- Brief Summary
The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Humeral Reconstruction Prosthesis in shoulder arthroplasty over time. This study will follow subjects for a period of up to 10 years post-surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
- 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
- Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implentation should be delayed until infection is resolved
- Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
- Neuromuscular disorders that do not allow control of the joint
- SIgnigicant 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 adversely affect the function or longevity of the implant
- Patient is pregnant
- Patient is a prisoner
- Patient has a physical or mental condition that would invalidate the results
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SST-12 Through study completion, an average of 1 per year Shoulder Simple Test (SST) - 12 questions with yes/no responses that measure shoulder pain and function from a patient's perspective - 12 yes corresponds to 100%
SPADI Through study completion, an average of 1 per year Shoulder Pain and Disability Index (SPADI) -13 questions assessing about pain scale (5 questions) and disability scale (8 questions) where 0 indicates no pain/no difficulty and 10 indicates worst pain imaginable/so difficult it requires help while performin these activities
Constant 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
UCLA Through study completion, an average of 1 per year University of California Los Angeles Shoulder Score (UCLA) - 5 Items score which combines both physician (3 items) and patient assessment (2 items) whith a total range from 0-35 where 0 indicates worse shoulder function and 35 better shoulder function outcomes
ASES 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
MSTS 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
TESS 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Western Orthopaedics Research and Education Foundation
🇺🇸Denver, Colorado, United States