Chronically Infected Total Hip of Knee Prosthesis
Conditions
Keywords
Total hip prosthesis, Total knee prosthesis, Chronic infection, One stage exchange, Two stage exchange, Cost-effectiveness
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.
Interventions
PROCEDUREExchange of total hip or knee arthroplasty on same time
Removal of the index implants, extensive debridement, reimplantation of a new prosthesis
PROCEDUREExchange 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
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cost-utility ratio (ICER) | 12 months post-operative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Quality of life : EQ-5D questionnaire | 12 months post-operative | Patient-reported generic (EQ-5D) outcomes questionnaire |
| Cost of complication treatment | 12 months post-operative | — |
| 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 whole treatment | 12 months post-operative | — |
| Duration of whole treatment | 12 months post-operative | — |
Countries
France
Contacts
Primary ContactHélène SOAVELO
Outcome results
None listed