NCT06518993

Observational Study to Collect Safety Data and PROMs on Primary THA

Observational Study to Collect Safety Data and Patient-reported Outcomes Measures (PROMs) on Retrospective Primary Total Hip Arthroplasty Surgeries With Trinity Cup and Meije Duo Cementless Hip Stem

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 116 (actual)
• Sponsor: Corin · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This observational study is designed to collect safety data and PROMs on retrospective primary total hipa arthroplasty surgeries with Trinity cup and Meije Duo cementless hip system

Detailed description

The major goal of this study is to collect safety and patient-reported outcomes measures (PROMs) data on Trinity cup in combination with Meije Duo cementless hip stem when used in primary total hip arthroplasty (THA). Data collected from this study will be fed into the Post-Market Surveillance (PMS) and Clinical Evaluation processes of the devices under assessment annually and support presentations at orthopaedic congresses and/or peer-reviewed publication(s) on mid- and long-term safety and clinical performance.

Conditions

• Hip Arthritis
• Osteoarthritis, Hip
• Coxitis
• Femoral Head Necrosis
• Femoral Neck Fractures

Interventions

Type	Name	Description
DEVICE	Total hip arthroplasty with a Trinity cup and a Meije Duo cementless stem	Subjects clinically suitable for a primary THR surgery with Trinity cup and Meije Duo cementless femoral stem.

Timeline

• Start date: 2024-04-19
• Primary completion: 2025-06-20
• Completion: 2025-06-20
• First posted: 2024-07-25
• Last updated: 2025-07-09

Locations

1 site across 1 country: France