DAIR for Infected Total Hip Arthroplasty - Does the Operative Approach Influence the Functional Result?

Completed

• Conditions: Hip Prosthesis Infection; Arthroplasty Complications
• Interventions: Procedure: Transgluteal approach to the hip joint; Procedure: Posterior approach to the hip joint

• Registration Number: NCT03161990
• Lead Sponsor: University Hospital, Akershus

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.

Study Timeline

• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-22
• Study Start: 2018-04-23
• Primary Completion: 2018-11-17
• Study Completion: 2018-11-17
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-17
• Last Update Posted: 2019-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transgluteal approach to the hip joint	Transgluteal approach to the hip joint	Patients who have been revised once for an infected total hip replacement with debridement and implant retention and in whom both the primary hip arthroplasty and the revision procedure were performed through a transgluteal approach.
Posterior approach to the hip joint	Posterior approach to the hip joint	Patients who have been revised once for an infected total hip replacement with debridement and implant retention and in whom both the primary hip arthroplasty and the revision procedure were performed through a posterior approach.

Primary Outcome Measures

Name	Time	Method
Function subscale score of the WOMAC	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 Outcome Measures

Name	Time	Method
WOMAC score	At minimum 1 year, on average 5 year follow-up from the DAIR procedure	Western Ontario and McMaster Universities osteoarthritis index score
Other complications	At minimum 1 year, on average 5 year follow-up from the DAIR procedure	Patient reported nerve injury, dislocation, reoperation for other causes than infection.
HOOS	At minimum 1 year, on average 5 year follow-up from the DAIR procedure	Hip Disability Osteoarthritis Score
EQ-5D score	At minimum 1 year, on average 5 year follow-up from the DAIR procedure	Quality of life score
Overall satisfaction	At minimum 1 year, on average 5 year follow-up from the DAIR procedure	Overall satisfaction with the revised total hip replacement assessed by questionnaire.
Limping	At minimum 1 year, on average 5 year follow-up from the DAIR procedure	Patient reported limping on the side of the revised total hip replacement.

Trial Locations

Locations (1)

Akershus University hospital; 🇳🇴 Lørenskog, Norway