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Patient Reported Outcome After Dislocation of a Primary THA

Patient Reported Outcome After Dislocation of a Primary THA

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03860025
Enrollment
4000
Registered
2019-03-01
Start date
2019-01-01
Completion date
2019-08-01
Last updated
2019-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Dislocation, Quality of Life

Brief summary

The aim is to compare QOL and hip specific outcome measures in patients with a single or recurrent episode(s) of THA dislocation and patients with a THA without any dislocation.

Detailed description

Knowledge about the patient's own perception of both general health and more hip-related issues after experiencing a hip dislocation is lacking (19). Hip surgeons need this information in order to incorporate it with other objective aspects, when advising patients with their first hip dislocation. Due to the large study population, this study will provide solid information of what to expect after a hip dislocation and be the largest study ever conducted within this topic. Depending on the results, this study may change the path we choose to advise for our patients after single or recurrent dislocations. 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.

Interventions

OTHERNo intervention.

No intervention.

Sponsors

University of Southern Denmark
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum

Inclusion criteria

* patients with one or more events of hip dislocation after a primary THA * controls with a primary THA without events of hip dislocation

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
QOL (Quality of life)9 yearsMeasured by the EQ-5D questionnaire.
Hip function9 yearsMeasured by the HOOS questionnaire.

Secondary

MeasureTime frameDescription
Activity9 yearsMeasured by the UCLA activity questionnaire.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026