Exactech Hip Systems Post-Market Clinical Follow-up (PMCF)
Part of paid clinical trials in Tulsa, Oklahoma.
- Sponsor
- Exactech
- Study ID
- NCT05849961
- Status
- Recruiting
Conditions
- Hip Arthroplasty, Total
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Exactech Hip Systems — DEVICEThe Exactech Hip System comprises a fixed-bearing hip joint prostheses used in treating human hip joint diseases as part of THA. These prostheses include a combination of the components and are available in a range of sizes to accommodate varying anatomical requirements.
Study Details
A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems
Key Dates
- Start date
- Oct 13, 2023
- Status verified
- Jun 2024
- Primary completion
- Jul 31, 2036
- Completion
- Dec 31, 2036
Study Design
- Enrollment
- 2,946 participants (estimated)
Arms
- Arm: Prospective SubjectsEnrolled in the study pre-surgery. Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study.
- Arm: Retrospective to ProspectiveSubjects enrolled in the study post- surgery then continue to participate in the study prospectively. Subjects who agree to participate in the study that have undergone surgery prior to enrollment in the study. Data for these subjects will collected from the subject's medical record for the time period prior to enrollment in the study containing data pertaining to the index surgery (retrospective data) and from the patient after they are enrolled in the study during the post-operative time period (prospectively).
- Arm: Retrospective Only SubjectsSubjects enrolled in the study post-study surgery with no intent to continue as prospective subjects. Patient's clinical record includes a signed HIPAA waiver allowing for the use of clinical record data for the purpose of clinical research outside of the operating institution.
Primary Outcome Measure
Harris Hip Score [ Time Frame: Preoperative ]
Central Contacts
- Pearl Harris352-377-1140
- Alex Knisely352-474-9582
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Tulsa Bone & Joint Associates | Tulsa | Oklahoma | 74146 | Scott Dunitz, MD (PRINCIPAL_INVESTIGATOR) |
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