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

Not Applicable

• Conditions: Chronically Infected Total Hip of Knee Prosthesis

• Registration Number: NCT02651961
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Study Timeline

• Study First Submitted: 2015-11-25
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-11
• Status Verified: 2018-05
• Study Start: 2018-05-03
• Last Update Submitted: 2018-05-18
• Last Update Posted: 2018-05-22
• Primary Completion: 2022-10-02
• Study Completion: 2022-10-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cost-utility ratio (ICER)	12 months post-operative

Secondary Outcome Measures

Name	Time	Method
Quality of life : EQ-5D questionnaire	12 months post-operative	Patient-reported generic (EQ-5D) outcomes questionnaire
Duration of whole treatment	12 months post-operative
cost of whole treatment	12 months post-operative
Pain : VAS score	12 months post-operative	Patient-reported pain score with visual analogic scale
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	12 months post-operative	necessity of reoperation will be assessed with clinical examination
Operating time of all surgical procedures	procedure	operating time is from time of entrance in the operating room to time of the end of intervention (hh:mm)
Cost of repeat surgery	12 months post-operative
Quality of life : Oxford hip or knee questionnaires	12 months post-operative	Patient-reported specific (Oxford) outcomes questionnaire
Cost of complication treatment	12 months post-operative

Trial Locations

Locations (1)

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France