NCT05849961

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,946 (estimated)
• Sponsor: Exactech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Patient outcomes data is important for assessing the post-market safety and effectiveness of orthopedic medical devices. The purpose of this study is to collect clinical and patient outcomes and survivorship data for patients who have received or will receive an Exactech Hip System for total hip arthroplasty (THA) prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).

Conditions

• Hip Arthroplasty, Total

Interventions

Type	Name	Description
DEVICE	Exactech 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.

Timeline

• Start date: 2023-10-13
• Primary completion: 2036-07-31
• Completion: 2036-12-31
• First posted: 2023-05-09
• Last updated: 2024-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study