36 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement

NCT00953719 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2019-04-10

Study results available
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Summary

This study is a supplement to the 28 mm Ceramic-on-Ceramic study which was designed to evaluate artificial hips with a 28 mm ceramic head and liner to determine whether they perform as well as artificial hips with a 28 mm ceramic head and a polyethylene liner.

This arm of the study is designed to compare a 36 mm ceramic head and sleeve with a subset of the control (28mm ceramic head and a polyethylene sleeve) from the original study (G030075) (NCT#00208507) with additional follow-up, to determine if they perform as well.

Conditions

  • Non-inflammatory Degenerative Joint Disease

Interventions

DEVICE

36 mm ceramic head on a ceramic acetabular liner

Total hip replacement with a 36 mm ceramic head on a ceramic liner

DEVICE

28 mm ceramic head on a polyethylene acetabular liner

Total hip replacement with a 28 mm ceramic head on a polyethylene liner.

Sponsors & Collaborators

  • DePuy Orthopaedics

    lead INDUSTRY

Principal Investigators

  • Joel Politi, MD · Cardinal Orthopaedic Institute

  • Douglas Dennis, MD · Colorado Joint Replacement

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-01
Primary Completion
2008-08-01
Completion
2013-07-01

Countries

  • United States

Study Locations

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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 NCT00953719 on ClinicalTrials.gov