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

Arthroplasty Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03161990
• Other study ID #: 287901
• Status: Completed
• Start date: April 23, 2018
• Est. completion date: November 17, 2018

Study information

• Verified date: June 2019
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: November 17, 2018
• Est. primary completion date: November 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty Complications
• Hip Prosthesis Infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	Akershus University hospital	Lørenskog

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Akershus	Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (3)

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. 2013 Dec;68(12):2964-5. J Antimicrob Chemother. 2011 May;66(5):1203. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	WOMAC score	Western Ontario and McMaster Universities osteoarthritis index score	At minimum 1 year, on average 5 year follow-up from the DAIR procedure
Secondary	HOOS	Hip Disability Osteoarthritis Score	At minimum 1 year, on average 5 year follow-up from the DAIR procedure
Secondary	EQ-5D score	Quality of life score	At minimum 1 year, on average 5 year follow-up from the DAIR procedure
Secondary	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
Secondary	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
Secondary	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