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Post Market Clinical Follow-Up of the Zimmer Stafit Acetabular System

NCT04079114 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 166

Last updated 2020-06-30

Study results available
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Summary

This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2. The data collected from this study will serve the purpose of confirming safety and performance of the Zimmer Stafit Acetabular System.

Conditions

  • Osteoarthritis, Hip
  • Fracture of Hip
  • Avascular Necrosis of Hip
  • Dislocated Hip
  • Osteonecrosis
  • Post-traumatic; Arthrosis
  • Rheumatoid Arthritis
  • Subluxation Hip

Interventions

DEVICE

Patients who received the Stafit Acetabular System

Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Paola Vivoda · Zimmer Biomet

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-28
Primary Completion
2017-01-24
Completion
2019-07-15

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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 NCT04079114 on ClinicalTrials.gov