Clinical trial NCT02651961: Cost-effectiveness Evaluation of One Stage Versus Two Stage Exchange for Chronically Infected Total Hip and Total Knee Prostheses
Official title: Cost-effectiveness Evaluation of One Stage Versus Two Stage Exchange for Chronically Infected Total Hip and Total Knee Prostheses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronically Infected Total Hip of Knee Prosthesis
Keywords: Total hip prosthesis
Total knee prosthesis
Chronic infection
One stage exchange
Two stage exchange
Cost-effectiveness
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Chronic infection after total joint arthroplasty generally requires implant exchange. Two stage exchange is considered as the gold standard procedure. However, some authors suggest that one stage exchange may be as effective. No consensus exists in the current literature. The purpose of the study was to evaluate the cost of both strategies in comparison to their success rate.

Detailed description: The primary criterion will be the cost-utility ratio (ICER) at 12 months follow-up.

The secondary criteria will be:

* quality of life;
* pain;
* persistence or recurrence of infection;
* occurrence of complications ;
* necessity for reoperation.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Chronically infected total hip or knee arthroplasty requiring implant exchange
* Affiliation to a social security system
* Signed informed consent
* Effective contraception during all study

Exclusion Criteria:

* Repeat exchange after failure of a prior treatment for infection
* Multiple implant infection
* Infection due to mycobacteria or fungus
* Pregnancy / Breast feeding
* Patient under judicial protection
* Impossibility to give informed consent for any reason
* Participation to another study

Primary outcomes:
measure: Cost-utility ratio (ICER)
timeFrame: 12 months post-operative
Secondary outcomes:
measure: Quality of life : EQ-5D questionnaire
timeFrame: 12 months post-operative
measure: Pain : VAS score
timeFrame: 12 months post-operative
measure: Number of Persistence or recurrence of infection for all participants
timeFrame: 24 months post-operative
measure: Occurrence of complications
timeFrame: 24 months post-operative
measure: number of Necessity of reoperation for all patient
timeFrame: 12 months post-operative
measure: Operating time of all surgical procedures
timeFrame: procedure
measure: Duration of whole treatment
timeFrame: 12 months post-operative
measure: Cost of complication treatment
timeFrame: 12 months post-operative
measure: Cost of repeat surgery
timeFrame: 12 months post-operative
measure: Quality of life : Oxford hip or knee questionnaires
timeFrame: 12 months post-operative
measure: cost of whole treatment
timeFrame: 12 months post-operative
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Strasbourg's University Hospitals
name: Jean-Yves JENNY, PH
role: PRINCIPAL_INVESTIGATOR
References: