NCT05603728 Exactech Shoulder Post Market Clinical Follow-up Study
| NCT ID | NCT05603728 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Exactech |
| Condition | Osteo Arthritis Shoulders |
| Study Type | OBSERVATIONAL |
| Enrollment | 20,000 participants |
| Start Date | 2007-07-19 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20,000 participants in total. It began in 2007-07-19 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 * 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)
Contact & Investigator
Jonathan Wright, MD
PRINCIPAL INVESTIGATOR
UF Health Orthopaedics and Sports Medicine Institute
Frequently Asked Questions
Who can join the NCT05603728 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Osteo Arthritis Shoulders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05603728 currently recruiting?
Yes, NCT05603728 is actively recruiting participants. Contact the research team at rachael.craig@exac.com for enrollment information.
Where is the NCT05603728 trial being conducted?
This trial is being conducted at Laguna Woods, United States, Redwood City, United States, Stockton, United States, Denver, United States and 11 additional locations.
Who is sponsoring the NCT05603728 clinical trial?
NCT05603728 is sponsored by Exactech. The principal investigator is Jonathan Wright, MD at UF Health Orthopaedics and Sports Medicine Institute. The trial plans to enroll 20,000 participants.