NCT03680443

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 21, 2018

Completed
Last Updated

September 21, 2018

Status Verified

September 1, 2018

Enrollment Period

4.3 years

First QC Date

August 21, 2018

Last Update Submit

September 19, 2018

Conditions

Aseptic LooseningArthroplasty Complications

Keywords

revisionreinforcement

Outcome Measures

Primary Outcomes (1)

  • dual-mobility cup cemented (effectiveness in terms of aseptic loosening)

    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

Interventions

assembly in THA revisionOTHER

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.

Eligibility Criteria

Age19 Years - 94 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • \<19years
  • \> 94 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Patrice Mertl, MD, PhD

    CHU AMIENS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2018

First Posted

September 21, 2018

Study Start

January 1, 2013

Primary Completion

April 26, 2017

Study Completion

April 26, 2017

Last Updated

September 21, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share