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A Multicentre Trial to Compare Two Articulating Bearing Surfaces as Used in Cementless Primary Hip Arthroplasty

NCT01247038 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2017-06-21

No results posted yet for this study

Summary

The aim of this study is to demonstrate the non-inferiority of the ceramic-on-metal articulation using large diameter bearings (38mm to 60mm) compared to the metal on metal articulation using the same cup in regards to the composite clinical success (CCS) rate at 2 years postoperatively (delta = 10% minimum clinically significant difference in rates).

Conditions

Interventions

DEVICE

Metal on ceramic articulation

Metal on ceramic articulation against metal-on-metal articulation using the same Recap Acetabular cup

DEVICE

Metal-on-Metal

Metal on Metal articulation

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-07-10
Completion
2015-07-10

Countries

  • Bosnia and Herzegovina
  • South Africa

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 NCT01247038 on ClinicalTrials.gov