An observational study in Hip Prosthesis Infection and Arthroplasty Complications, sponsored by University Hospital, Akershus. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-18.
Sponsored by University Hospital, Akershus · Observational
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.
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.
University Hospital, Akershus is the lead sponsor of 123 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The potential study participant will be identified in the Norwegian Arthroplasty Register.
Exclusion Criteria:
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
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 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
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
Function subscale score of the WOMAC
Function subscale score of the Western Ontario and McMaster Universities osteoarthritis index (WOMAC)
Time frame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
WOMAC score
Western Ontario and McMaster Universities osteoarthritis index score
Time frame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
HOOS
Hip Disability Osteoarthritis Score
Time frame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
EQ-5D score
Quality of life score
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
Infection eradication
Patient reported eradication of the infection of their total hip arthroplasty.
Time frame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
Plan to share: No
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Akershus