Dual Mobility Cup in Total Hip Arthroplasty Preventing Dislocation in Patients at Risk

May 11, 2016 updated by: Sundsvall Hospital

Retrospectively study reviewing 34 patients operated with dual mobility cups in total hip arthroplasty between January 2009 and June 2012 at Sundsvall Hospital.

Hypothesis: The dual mobility socket reduce the rate of dislocation in patient at high risk but increase the incidence of postoperative infection.

Study Overview

Status

Completed

Conditions

Detailed Description

Retrospectively study reviewing 34 patients operated with dual mobility cups in total hip arthroplasty between January 2009 and June 2012 at Sundsvall Hospital.

Indications for surgery is recurrent dislocation or patients at risk for dislocation after total hip arthroplasty suffering osteoarthritis or femoral neck fracture.

Patients are followed recording complications, reoperations, functional outcome (Harris hip score and EQ5D) in june 2012.

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Västernorrlands län
      • Sundsvall, Västernorrlands län, Sweden, 851 86
        • Orthopaedic Department

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients operated with an cemented dual mobility cups at Sundsvall hospital between 2009-2012.

Indications for surgery are recurrent dislocation and patients at risk for dislocation mainly due to comorbidity, neuromuscular, psychiatric or cognitive disorders.

Description

Inclusion Criteria:

  • operated with an cemented dual mobility socket at Sundsvall hospital

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prosthetic dislocation
Time Frame: 2012 (up to 3 years postoperatively)
Incidence of postoperative dislocations of the prosthesis
2012 (up to 3 years postoperatively)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication
Time Frame: 2012 (up to 3 years postoperatively)
Incidence of complications and reoperations
2012 (up to 3 years postoperatively)
Hip function
Time Frame: 2012 (up to 3 years postoperatively)
Patient reported hip function; Harris hip score
2012 (up to 3 years postoperatively)
Quality of life
Time Frame: 2012 (up to 3 years postoperatively)
Patient reported quality of life: EQ5D
2012 (up to 3 years postoperatively)

Collaborators and Investigators

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

Sponsor

Sundsvall Hospital

Investigators

  • Principal Investigator: Arkan S Sayed Noor, MD, PhD, Landstinget Västernorrland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

June 24, 2012

First Submitted That Met QC Criteria

July 16, 2012

First Posted (Estimate)

July 19, 2012

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sebastian-1

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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