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Trial Title:
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
NCT ID:
NCT05615246
Condition:
Osteoarthritis Shoulder
Rheumatoid Arthritis
Oncology
Conditions: Official terms:
Osteoarthritis
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
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.
Criteria for eligibility:
Study pop:
- Patients who meet eligibility criteria
- Patients who consent to participate to return for follow-up visits out to 10 years
or longer
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Western Orthopaedics Research and Education Foundation
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Contact:
Last name:
Libby Mauter
Phone:
303-321-1333
Investigator:
Last name:
Armodios M Hatzidakis, MD
Email:
Principal Investigator
Start date:
September 5, 2018
Completion date:
September 30, 2031
Lead sponsor:
Agency:
Exactech
Agency class:
Industry
Source:
Exactech
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05615246
