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Clinical Trials/NCT03161990
NCT03161990
Completed
Not Applicable

Debridement, Antibiotics and Implant Retention (DAIR) for Infected Total Hip Arthroplasty- Does the Operative Approach Influence the Functional Result?

University Hospital, Akershus1 site in 1 country226 target enrollmentApril 23, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Prosthesis Infection
Sponsor
University Hospital, Akershus
Enrollment
226
Locations
1
Primary Endpoint
Function subscale score of the WOMAC
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The functional outcome and quality of life after treatment for an infected hip arthroplasty have been found to be significantly worse compared to an uncomplicated arthroplasty. However, the type of revision surgery chosen to treat the infection plays a role for the functional outcome. The concept of DAIR (debridement, antibiotics and implant retention) has been shown to yield god results with respect to infection control in cases of early infection with a stable implant and better functional results than a to-stage revision. In patients where infection control was achieved after just one DAIR procedure the functional outcome was comparable to an uncomplicated primary arthroplasty. However, it is not known if the operative approach used for the primary and revision surgery plays a role for the functional result after treatment of an infected total hip arthroplasty with DAIR. The project's aim is to investigate if the choice of the operative approach (transgluteal or posterior) for the primary hip replacement and the revision surgery has an influence on the functional result after debridement and implant retention for an infected total hip replacement.

Detailed Description

Potential study participants will be identified in the Norwegian Arthroplasty Register. Patients who have been revised once for an infected total hip arthroplasty with debridement and implant retention and in whom either the transgluteal og posterior operative approach was used in both procedures will be selected. The potential participants will be contacted by letter. They will be asked for written informed consent and to fill out three questionnaires: the Hip Disability Osteoarthritis Score (HOOS), which also allows for the calculation of the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), the EQ-5D (quality of life) and a questionnaire asking about confirmation that the patient only has been revised once for his/her infected arthroplasty, about limping, other complications (nerve injury, dislocation, reoperation for other causes than infection), if the infection is considered to have been eradicated and overall satisfaction. The data recorded in the Norwegian Arthroplasty Register will be used in a multiple linear regression analysis to evaluate if the surgical approach is an independent factor influencing the outcome measures.

Registry
clinicaltrials.gov
Start Date
April 23, 2018
End Date
November 17, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Akershus
Responsible Party
Principal Investigator
Principal Investigator

Asbjorn Aroen

Professor

University Hospital, Akershus

Eligibility Criteria

Inclusion Criteria

  • The infected total hip arthroplasty has only been revised once.
  • The revision procedure was a debridement and implant retention.
  • Both, the primary and the revision procedure were performed through the same surgical approach; either the transgluteal or the posterior approach.

Exclusion Criteria

  • No written informed consent.

Outcomes

Primary Outcomes

Function subscale score of the WOMAC

Time Frame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure

Function subscale score of the Western Ontario and McMaster Universities osteoarthritis index (WOMAC)

Secondary Outcomes

  • WOMAC score(At minimum 1 year, on average 5 year follow-up from the DAIR procedure)
  • Other complications(At minimum 1 year, on average 5 year follow-up from the DAIR procedure)
  • HOOS(At minimum 1 year, on average 5 year follow-up from the DAIR procedure)
  • EQ-5D score(At minimum 1 year, on average 5 year follow-up from the DAIR procedure)
  • Overall satisfaction(At minimum 1 year, on average 5 year follow-up from the DAIR procedure)
  • Limping(At minimum 1 year, on average 5 year follow-up from the DAIR procedure)

Study Sites (1)

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