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Completed

NCT Number: NCT03161990

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Akershus University hospital

Lørenskog, 1478, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Direct lateral 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.

Other names: Posterolateral approach to the hip joint

Primary outcomes

  1. Function subscale score of the WOMAC

    Time frame: 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 outcomes

  1. WOMAC score

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

    Western Ontario and McMaster Universities osteoarthritis index score

  2. HOOS

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

    Hip Disability Osteoarthritis Score

  3. EQ-5D score

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

    Quality of life score

  4. Limping

    Time frame: 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.

  5. Other complications

    Time frame: 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.

  6. Overall satisfaction

    Time frame: 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.

Other outcomes

  1. Infection eradication

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

    Patient reported eradication of the infection of their total hip arthroplasty.

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • Haukeland University Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 22, 2017
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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