NCT03226808

Vivacit-E Post-market Follow-up Study

Post Market Clinical Follow-up Study of the Zimmer Vivacit-E Highly Crosslinked Polyethylene Liner Used With the Continuum Acetabular Shell

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to obtain clinical performance (outcomes) data and survivorship for commercially available Vivacit-E (HXPE) liners. This will be done by analysis of polyethylene wear, validated outcome measurement tools, radiographs, and reported adverse events data.

Detailed description

Safety will be evaluated by monitoring the frequency and incidence of adverse events. Performance will be determined by assessment of the overall pain and functional performances, survivorship, health status and radiographic parameters of all enrolled study subjects who receive the Vivacit-E HXPE Liner with the Continuum acetabular shell. In addition, the implanted Vivacit-E HXPE Liners will be evaluated for bedding in, and linear and volumetric wear by the Martell 2-D method at 6 weeks and 1, 2, 4, \& 5 years postoperatively. Pain and functional performance will be measured using the Harris Hip and High Activity Arthroplasty Scores. Survivorship will be based on removal or intended removal of the device and through analysis of radiographs, and health status will be determined by evaluation of the EQ-5D.

Conditions

• Osteoarthritis
• Avascular Necrosis of Bone of Hip
• Post-traumatic; Arthrosis
• Congenital Hip Dysplasia

Interventions

Type	Name	Description
DEVICE	Vivacit-E Liner	All subjects enrolled will receive the Vivacit-E liner.

Timeline

• Start date: 2013-10-01
• Primary completion: 2026-03-02
• Completion: 2028-06-30
• First posted: 2017-07-24
• Last updated: 2025-01-01

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study