NCT04731077

Avenir Complete Post-Market Clinical Follow-Up Study

Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the Avenir Complete™ Femoral Stem (Implants and Instrumentation)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 275 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty.

Detailed description

The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete™ femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty: The primary endpoint is defined by the survival of the implant system at 10 years, which is based on the removal or intended removal of the "study device and determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).

Conditions

• Osteoarthritis, Hip
• Avascular Necrosis of Hip
• Avascular Necrosis of the Femoral Head
• Post-traumatic; Arthrosis

Interventions

Type	Name	Description
DEVICE	Avenir Complete Femoral Stem	All enrolled subjects will receive the Avenir Complete Femoral Stem

Timeline

• Start date: 2021-09-27
• Primary completion: 2035-06-01
• Completion: 2036-06-01
• First posted: 2021-01-29
• Last updated: 2025-06-18

Locations

9 sites across 6 countries: United States, Denmark, Japan, Netherlands, Norway, Sweden

Regulatory

• FDA-regulated device study