"Patient Reported Outcome After Dislocation of a Primary THA"

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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Hip Dislocation
• Intervention / Treatment: Other: No intervention.

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.

• Study Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

Study Locations

• Denmark
  • Region Of Southern Denmark
    • Esbjerg, Region Of Southern Denmark, Denmark, 6700
      • Hospital of South West Jutland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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. Cases are found in a previously described study (Protocol-ID 3-3013-2128/1). 1100-1800 cases will be identified, anticipated.

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

Description

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:

-

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single dislocation.; Patients with a single postoperative hip dislocation without subsequent revision surgery.	Other: No intervention.; No intervention.
Recurrent dislocation.; Patients with two or more postoperative hip dislocations without subsequent revision surgery.	Other: No intervention.; No intervention.
Revision due to dislocation.; Patients with one or more postoperative hip dislocations with subsequent revision surgery due to recurrent instability.	Other: No intervention.; No intervention.
Controls.; Matched patients without postoperative hip dislocation or revision of any reason.	Other: No intervention.; No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QOL (Quality of life)	Measured by the EQ-5D questionnaire.	9 years
Hip function	Measured by the HOOS questionnaire.	9 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity	Measured by the UCLA activity questionnaire.	9 years

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Investigators: Principal Investigator: Lars L. Hermansen, MD, Department of Clinical Research, Odense University Hospital, Odense, Denmark.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: February 28, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 28, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Hip Injuries; Hip Dislocation; Joint Dislocations
• Other Study ID Numbers: 3-3013-2128/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data not to be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No