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

N/AUnknownNCT02651961

University Hospital, Strasbourg, France100 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Chronically Infected Total Hip of Knee Prosthesis

Interventions

Exchange of total hip or knee arthroplasty on same timePROCEDURE

Removal of the index implants, extensive debridement, reimplantation of a new prosthesis

Exchange of total hip or knee arthroplasty in two timePROCEDURE

Removal of the index implants in first time, extensive debridement, reimplantation of a new prosthesis in seconde time

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

RECRUITING

Outcomes

Primary Outcomes

Cost-utility ratio (ICER)

Time frame: 12 months post-operative

Secondary Outcomes

Quality of life : EQ-5D questionnaire

Patient-reported generic (EQ-5D) outcomes questionnaire

Time frame: 12 months post-operative

Pain : VAS score

Patient-reported pain score with visual analogic scale

Time frame: 12 months post-operative

Number of Persistence or recurrence of infection for all participants

Time frame: 24 months post-operative

Occurrence of complications

Time frame: 24 months post-operative

number of Necessity of reoperation for all patient

necessity of reoperation will be assessed with clinical examination

Time frame: 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)

Time frame: procedure

Duration of whole treatment

Time frame: 12 months post-operative

Cost of complication treatment

Time frame: 12 months post-operative

Cost of repeat surgery

Time frame: 12 months post-operative

Central Contacts

Hélène SOAVELO

CONTACT

+33388116559 helene.soavelo@chru-strasbourg.fr

Data from ClinicalTrials.gov

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