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 — DEVICE
    The 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 Subjects
    Enrolled 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 Prospective
    Subjects 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 Subjects
    Subjects 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

Locations (1)

FacilityCityStateZIPSite coordinators
Tulsa Bone & Joint AssociatesTulsaOklahoma74146
Faye Biggs
918-392-1400
Scott Dunitz, MD (PRINCIPAL_INVESTIGATOR)

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