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

University Hospital, Strasbourg, France1 site in 1 country100 target enrollmentMay 3, 2018

ConditionsChronically Infected Total Hip of Knee Prosthesis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronically Infected Total Hip of Knee Prosthesis
Sponsor: University Hospital, Strasbourg, France
Enrollment: 100
Locations: 1
Primary Endpoint: Cost-utility ratio (ICER)
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 3, 2018

End Date

October 2, 2022

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Strasbourg, France

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Cost-utility ratio (ICER)

Time Frame: 12 months post-operative

Secondary Outcomes

Quality of life : EQ-5D questionnaire(12 months post-operative)
Duration of whole treatment(12 months post-operative)
cost of whole treatment(12 months post-operative)
Pain : VAS score(12 months post-operative)
Number of Persistence or recurrence of infection for all participants(24 months post-operative)
Cost of complication treatment(12 months post-operative)
Occurrence of complications(24 months post-operative)
number of Necessity of reoperation for all patient(12 months post-operative)
Operating time of all surgical procedures(procedure)
Cost of repeat surgery(12 months post-operative)
Quality of life : Oxford hip or knee questionnaires(12 months post-operative)