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

NCT03161990 | Completed

• 1 other identifier: 287901
• Study Type: observational
• Target: 226
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Prosthesis Infection; Arthroplasty Complications

Keywords

DAIR; Transgluteal approach; Posterior approach

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• WOMAC score

  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

• Limping

  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

Other Outcomes (1)

• Infection eradication

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

Study Arms (2)

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

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

Interventions

Transgluteal approach to the hip joint PROCEDURE

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.

Also known as: Direct lateral approach to the hip joint

Transgluteal approach to the hip joint

Posterior approach to the hip joint PROCEDURE

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.

Also known as: Posterolateral approach to the hip joint

Posterior approach to the hip joint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• No written informed consent.

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Haukeland University Hospital: collaborator

Study Sites (1)

Akershus University hospital

Lørenskog, 1478, Norway

Location

Related Publications (4)

• 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.

  PMID: 18453662 BACKGROUND

• 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.

  PMID: 19336454 BACKGROUND

• 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.

  PMID: 28385345 BACKGROUND

• 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.

  PMID: 33249901 DERIVED

Study Officials

• Asbjorn Aaroen, Professor

  University Hospital, Akershus

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 22, 2017
• Study Start: April 23, 2018
• Primary Completion: November 17, 2018
• Study Completion: November 17, 2018
• Last Updated: June 18, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)