RecruitingNCT05849961

Exactech Hip Systems Post-Market Clinical Follow-up (PMCF)

TM-2023-017318 Exactech Hip Systems PMCF: A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems


Sponsor

Exactech

Enrollment

2,946 participants

Start Date

Oct 13, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a long-term follow-up study tracking the real-world performance of Exactech hip replacement systems in patients who have undergone total hip arthroplasty (THA). Hip replacement is one of the most common and successful orthopedic surgeries performed, but implant performance can vary depending on design, surgical technique, and patient factors. Post-market registries like this one track outcomes over years — including revision rates, complications, and patient-reported function — to ensure devices continue to perform safely after receiving regulatory approval. The study includes three cohorts: patients enrolling before surgery (prospective), patients who have already had surgery and now consent to prospective follow-up (combined retrospective/prospective), and patients whose data is collected purely from medical records without additional follow-up. All participants must be adults (18+) who received an Exactech hip implant for an approved indication. Pregnant women, prisoners, and patients with metal allergies contraindicating the device are excluded. Post-market surveillance is not glamorous science, but it is essential. It's how problems with implants — like wear patterns or unusual failure modes — get detected before they affect thousands more patients. This study provides the ongoing safety and effectiveness data that regulators, surgeons, and patients rely on to make informed decisions about hip replacement options.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEExactech Hip Systems

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.


Locations(1)

Tulsa Bone & Joint Associates

Tulsa, Oklahoma, United States

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NCT05849961


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