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

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.

Study Overview

• Status: Unknown
• Conditions: Chronically Infected Total Hip of Knee Prosthesis
• Intervention / Treatment: Procedure: Exchange of total hip or knee arthroplasty on same time; Procedure: Exchange of total hip or knee arthroplasty in two time

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67000
    • Recruiting
    • Hopitaux Universitaires de Strasbourg
    • Contact: Jean-Yves JENNY, MD; Phone Number: 0388552456; Email: jean-yves.jenny@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Jean-Yves JENNY, PH, Strasbourg's University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2018
• Primary Completion (Anticipated): October 2, 2022
• Study Completion (Anticipated): October 2, 2022

Study Registration Dates

• First Submitted: November 25, 2015
• First Submitted That Met QC Criteria: January 7, 2016
• First Posted (Estimate): January 11, 2016

Study Record Updates

• Last Update Posted (Actual): May 22, 2018
• Last Update Submitted That Met QC Criteria: May 18, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Cost-effectiveness; Total hip prosthesis; Total knee prosthesis; Chronic infection; One stage exchange; Two stage exchange
• Other Study ID Numbers: 6262

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No