Clinical trial NCT03161990: DAIR for Infected Total Hip Arthroplasty - Does the Operative Approach Influence the Functional Result?
Official title: Debridement, Antibiotics and Implant Retention (DAIR) for Infected Total Hip Arthroplasty- Does the Operative Approach Influence the Functional Result?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Prosthesis Infection
Arthroplasty Complications
Keywords: DAIR
Transgluteal approach
Posterior approach
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
First posted: 2017-05-22
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The potential study participant will be identified in the Norwegian Arthroplasty Register.

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.

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.

Primary outcomes:
measure: Function subscale score of the WOMAC
timeFrame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
Secondary outcomes:
measure: WOMAC score
timeFrame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
measure: HOOS
timeFrame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
measure: EQ-5D score
timeFrame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
measure: Limping
timeFrame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
measure: Other complications
timeFrame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
measure: Overall satisfaction
timeFrame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
Other outcomes:
measure: Infection eradication
timeFrame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
Locations:
city: Lørenskog
country: Norway
facility: Akershus University hospital
Study officials:
affiliation: University Hospital, Akershus
name: Asbjorn Aaroen, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.