Cost-effectiveness Evaluation of One Stage Versus Two Stage Exchange for Chronically Infected Total Hip and Total Knee Prostheses

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cost-effectiveness Evaluation of One Stage Versus Two Stage Exchange for Chronically Infected Total Hip and Total Knee Prostheses

Conditions
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Chronically Infected Total Hip of Knee Prosthesis

Intervention / Treatment
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* Procedure: Exchange of total hip or knee arthroplasty on same time
* Procedure: Exchange of total hip or knee arthroplasty in two time


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: One stage exchange<br>One stage exchange of the chronically infected implant | Procedure: Exchange of total hip or knee arthroplasty on same time<br>* Removal of the index implants, extensive debridement, reimplantation of a new prosthesis<br>|
| Active Comparator: Two stage exchange<br>Two stage exchange of the chronically infected implant | Procedure: Exchange of total hip or knee arthroplasty in two time<br>* Removal of the index implants in first time, extensive debridement, reimplantation of a new prosthesis in seconde time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-utility ratio (ICER) |  | 12 months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life : EQ-5D questionnaire | Patient-reported generic (EQ-5D) outcomes questionnaire | 12 months post-operative | 
| Pain : VAS score | Patient-reported pain score with visual analogic scale | 12 months post-operative | 
| Number of Persistence or recurrence of infection for all participants |  | 24 months post-operative | 
| Occurrence of complications |  | 24 months post-operative | 
| number of Necessity of reoperation for all patient | necessity of reoperation will be assessed with clinical examination | 12 months post-operative | 
| Operating time of all surgical procedures | operating time is from time of entrance in the operating room to time of the end of intervention (hh:mm) | procedure | 
| Duration of whole treatment |  | 12 months post-operative | 
| Cost of complication treatment |  | 12 months post-operative | 
| Cost of repeat surgery |  | 12 months post-operative | 
| Quality of life : Oxford hip or knee questionnaires | Patient-reported specific (Oxford) outcomes questionnaire | 12 months post-operative | 
| cost of whole treatment |  | 12 months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total hip prosthesis, Total knee prosthesis, Chronic infection, One stage exchange, Two stage exchange, Cost-effectiveness