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Vivacit-E Post-market Follow-up Study

NCT03226808 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2025-01-01

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Vivacit-E Liner

All subjects enrolled will receive the Vivacit-E liner.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Ryan Boylan, MBA · Zimmer Biomet

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-01
Primary Completion
2026-03-02
Completion
2028-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03226808 on ClinicalTrials.gov