"Patient Reported Outcome After Dislocation of a Primary THA"

NCT03860025 | Unknown DMC

• 1 other identifier: 3-3013-2128/2
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Hip Dislocation

Outcome Measures

Primary Outcomes (2)

• QOL (Quality of life)

  Measured by the EQ-5D questionnaire.

  9 years

• Hip function

  Measured by the HOOS questionnaire.

  9 years

Secondary Outcomes (1)

• Activity

  9 years

Study Arms (4)

Single dislocation.

Patients with a single postoperative hip dislocation without subsequent revision surgery.

Other: No intervention.

Recurrent dislocation.

Patients with two or more postoperative hip dislocations without subsequent revision surgery.

Other: 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.

Controls.

Matched patients without postoperative hip dislocation or revision of any reason.

Other: No intervention.

Interventions

No intervention. OTHER

No intervention.

Controls.; Recurrent dislocation.; Revision due to dislocation.; Single dislocation.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Hospital of South West Jutland

Esbjerg, Region Syddanmark, 6700, Denmark

Location

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Study Officials

• Lars L. Hermansen, MD

  Department of Clinical Research, Odense University Hospital, Odense, Denmark.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 1, 2019
• Study Start: January 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: March 1, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)