Rheumatoid Arthritis Clinical Trial
— HRPOfficial title:
An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty
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 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.
Status | Recruiting |
Enrollment | 100 |
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, 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 |
Country | Name | City | State |
---|---|---|---|
United States | Western Orthopaedics Research and Education Foundation | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
Exactech |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SST-12 | 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% | Through study completion, an average of 1 per year | |
Primary | SPADI | 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 | Through study completion, an average of 1 per year | |
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 | UCLA | 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 | Through study completion, an average of 1 per year | |
Primary | TESS | 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 | 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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