Total Hip Arthoplastry Revision by Dual-mobility Acetabular Cup Cemented in a Metal Reinforcement (PTH)

September 19, 2018 updated by: Centre Hospitalier Universitaire, Amiens

Total Hip Arthoplastry Revision by Dual-mobility Acetabular Cup Cemented in a Metal Reinforcement: A 62 Case Series at a Minimum 5 Years Follow-up

Total hip arthroplasty (THA) requires bone reconstruction in case of severe acetabular injury, with risk of dislocation, especially postoperatively. Dual-mobility cups have proved effective in preventing dislocation in THA revision for instability, but their behavior when cemented in a metal reinforcement has been little studied.

The present study assessed results for a dual-mobility cup cemented in a metal reinforcement, in terms of aseptic loosening and postoperative instability.

A single-center continuous series of 62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Total hip arthroplasty (THA) requires bone reconstruction in case of severe acetabular injury, with risk of dislocation, especially postoperatively. Dual-mobility cups have proved effective in preventing dislocation in THA revision for instability, but their behavior when cemented in a metal reinforcement has been little studied.

The present study assessed results for a dual-mobility cup cemented in a metal reinforcement, in terms of aseptic loosening and postoperative instability.

A single-center continuous series of 62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up. Failure due to aseptic loosening or instability and implant survival at last follow-up were analyzed.

Study Type

Observational

Enrollment (Actual)

62

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 94 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up. Failure due to aseptic loosening or instability and implant survival at last follow-up were analyzed.

Description

Inclusion Criteria:

  • patients between 19 and 84 years
  • patients receiving such an assembly in THA revision

Exclusion Criteria:

  • <19years
  • > 94 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dual-mobility cup cemented (effectiveness in terms of aseptic loosening)
Time Frame: 5 years
The objective of the present study is to evaluate the most effective type of assembly , dual-mobility cup cemented in a metal reinforcement, in terms of aseptic loosening in the prevention of dislocation during the revision of the total hip arthroplasty (THA)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Patrice Mertl, MD, PhD, CHU Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2013

Primary Completion (ACTUAL)

April 26, 2017

Study Completion (ACTUAL)

April 26, 2017

Study Registration Dates

First Submitted

August 21, 2018

First Submitted That Met QC Criteria

September 19, 2018

First Posted (ACTUAL)

September 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2018

Last Update Submitted That Met QC Criteria

September 19, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PI2017_843_0041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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