NCT05849961 Exactech Hip Systems Post-Market Clinical Follow-up (PMCF)
| NCT ID | NCT05849961 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Exactech |
| Condition | Hip Arthroplasty, Total |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,946 participants |
| Start Date | 2023-10-13 |
| Primary Completion | 2036-07-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems
Eligibility Criteria
Inclusion Criteria: Cohort 1: * Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study. * Skeletally mature (18 years of age or older). * The subject is willing and able to provide written informed consent for participation in the study. * Subject is to receive an Exactech Hip System THA for any approved indication for use. * The hip replacement will be performed by the investigator or a surgeon sub- investigator. * The devices will be used according to the approved indications. Cohort 2: * Subjects who agree to participate in the study that have undergone surgery prior to enrollment in the study. Data for these subjects will be collected from the subject's medical record for the time-period prior to enrollment in the study containing data pertaining to the preoperative time period and index surgery (retrospective data) and from the patient after they are enrolled in the study during the post-operative time- period (prospectively).