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

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

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.

Study Overview

• Status: Completed
• Conditions: Arthroplasty Complications; Hip Prosthesis Infection
• Intervention / Treatment: Procedure: Transgluteal approach to the hip joint; Procedure: Posterior approach to the hip joint

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 Type: Observational
• Enrollment (Actual): 226

Contacts and Locations

Study Locations

• Norway
  • Lørenskog, Norway, 1478
    • Akershus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The potential study participant will be identified in the Norwegian Arthroplasty Register.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Transgluteal approach to the hip joint; Operative approach to the hip joint where the abductors are partly detached from the greater trochanter and the hip joint is approached through the anterior part of the capsule.; Other Names: Direct lateral 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.	Procedure: Posterior approach to the hip joint; Operative approach to the hip joint where the short external rotators are detached from the greater trochanter and the hip joint is approached through the posterior part of the capsule.; Other Names: Posterolateral approach to the hip joint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Function subscale score of the WOMAC	Function subscale score of the Western Ontario and McMaster Universities osteoarthritis index (WOMAC)	At minimum 1 year, on average 5 year follow-up from the DAIR procedure

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection eradication	Patient reported eradication of the infection of their total hip arthroplasty.	At minimum 1 year, on average 5 year follow-up from the DAIR procedure

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Collaborators: Haukeland University Hospital

Publications and helpful links

General Publications

• Cahill JL, Shadbolt B, Scarvell JM, Smith PN. Quality of life after infection in total joint replacement. J Orthop Surg (Hong Kong). 2008 Apr;16(1):58-65. doi: 10.1177/230949900801600115.
• Byren I, Bejon P, Atkins BL, Angus B, Masters S, McLardy-Smith P, Gundle R, Berendt A. One hundred and twelve infected arthroplasties treated with 'DAIR' (debridement, antibiotics and implant retention): antibiotic duration and outcome. J Antimicrob Chemother. 2009 Jun;63(6):1264-71. doi: 10.1093/jac/dkp107. Epub 2009 Mar 31. Erratum In: J Antimicrob Chemother. 2011 May;66(5):1203. J Antimicrob Chemother. 2013 Dec;68(12):2964-5.
• Grammatopoulos G, Kendrick B, McNally M, Athanasou NA, Atkins B, McLardy-Smith P, Taylor A, Gundle R. Outcome Following Debridement, Antibiotics, and Implant Retention in Hip Periprosthetic Joint Infection-An 18-Year Experience. J Arthroplasty. 2017 Jul;32(7):2248-2255. doi: 10.1016/j.arth.2017.02.066. Epub 2017 Mar 6.
• Pollmann CT, Gjertsen JE, Dale H, Straume-Naesheim TM, Dybvik E, Hallan G. Operative approach influences functional outcome after DAIR for infected total hip arthroplasty. Bone Joint J. 2020 Dec;102-B(12):1662-1669. doi: 10.1302/0301-620X.102B12.BJJ-2020-0501.R1.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2018
• Primary Completion (Actual): November 17, 2018
• Study Completion (Actual): November 17, 2018

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): June 18, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Posterior approach; DAIR; Transgluteal approach
• Other Study ID Numbers: 287901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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