NCT05848024

EBRA Study AMISTEM-C FR

Prospective, Single-Center, Non-Controlled, Non-Randomized, Open Study Evaluating the Performance and Stability of Amistem® C

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Medacta International SA · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Primary objective: Evaluate femoral stem migration Secondary objective: Evaluate the performance of AMIStem H Proximal Coating at 10 years after surgery; assessment of functional recovery; radiological evaluation; reporting of complications Scores collected: HHS, OHS, PMA, UCLA

Detailed description

The main objective of the study was to evaluate the migration and performance of the AMIStem® C femoral stem at 10 years follow-up. The primary endpoint is the measurement of femoral component migration by EBRA-FCA (The Ein Bild Roentgen Analyse-femoral component analysis, Innsbruck, Austria) The secondary objectives of the study are: Evaluate the performance of the AMIStem® C stem Evaluate the function of the operated hip To evaluate the quality of life To evaluate the safety of the AMIStem® C femoral stem Evaluate the postoperative stability and fixation of the hip prosthesis

Conditions

• Total Hip Arthroplasty

Timeline

• Start date: 2017-02-08
• Primary completion: 2027-02-01
• Completion: 2029-02-01
• First posted: 2023-05-08
• Last updated: 2025-09-29

Locations

1 site across 1 country: France