"Patient Reported Outcome After Dislocation of a Primary THA"
NCT ID: NCT03860025
Last Updated: 2019-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
4000 participants
OBSERVATIONAL
2019-01-01
2019-08-01
Brief Summary
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Detailed Description
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A matched case-control study involving the share of THA patients with at least 1 episode of hip dislocation.
The patients had undergone primary surgery in the 5-year period from 01.01.2010 - 31.12.2014 and subsequent dislocation was evaluated in a 2-year follow-up period. Given a 3-5% approximated incidence of dislocation, 1100-1800 cases will have been identified.
Patients are subdivided in groups depending on the number of dislocations and one group containing THA revisions. In order to be included, a time frame of at least 0,5 year since the last episode of dislocation or surgery must have passed.
A matched control group of patients with primary THA without any event of dislocation are located from the original 5-year period of primary surgery. They will be matched with the group of patients with dislocation, regarding to:
1. Age (+/- 5 years)
2. Gender
3. Date of surgery and hospital
The study will be conducted in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.
After 01.01.2019, all patients included will be receiving 3 questionnaires (a generic - EQ-5D, a hip-specific - HOOS, and an activity scale - UCLA) by e-boks (a mandatory secure email system couplet to the patient's CPR number). Some elderly are exempt and will instead receive the questionnaires by regular mail and a pre-labeled return envelope is attached. Reminders are sent after 2 months.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Single dislocation.
Patients with a single postoperative hip dislocation without subsequent revision surgery.
No intervention.
No intervention.
Recurrent dislocation.
Patients with two or more postoperative hip dislocations without subsequent revision surgery.
No intervention.
No intervention.
Revision due to dislocation.
Patients with one or more postoperative hip dislocations with subsequent revision surgery due to recurrent instability.
No intervention.
No intervention.
Controls.
Matched patients without postoperative hip dislocation or revision of any reason.
No intervention.
No intervention.
Interventions
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No intervention.
No intervention.
Eligibility Criteria
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Inclusion Criteria
* controls with a primary THA without events of hip dislocation
Exclusion Criteria
40 Years
ALL
No
Sponsors
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University of Southern Denmark
OTHER
Responsible Party
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Principal Investigators
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Lars L. Hermansen, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Clinical Research, Odense University Hospital, Odense, Denmark.
Locations
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Hospital of South West Jutland
Esbjerg, Region Syddanmark, Denmark
Countries
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Other Identifiers
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3-3013-2128/2
Identifier Type: -
Identifier Source: org_study_id
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