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

University Hospital, Strasbourg, France

Status: Unknown

Conditions: Chronically Infected Total Hip of Knee Prosthesis

Treatments: Procedure: Exchange of total hip or knee arthroplasty on same time; Procedure: Exchange of total hip or knee arthroplasty in two time

Study type: Interventional

Funder types: Other

Identifiers

NCT02651961

6262

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

One stage exchange

Active Comparator group

Description:

One stage exchange of the chronically infected implant

Treatment:

Procedure: Exchange of total hip or knee arthroplasty on same time

Two stage exchange

Active Comparator group

Description:

Two stage exchange of the chronically infected implant

Treatment:

Procedure: Exchange of total hip or knee arthroplasty in two time