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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One stage exchange | Active Comparator | One stage exchange of the chronically infected implant |
|
| Two stage exchange | Active Comparator | Two stage exchange of the chronically infected implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exchange of total hip or knee arthroplasty on same time | Procedure | Removal of the index implants, extensive debridement, reimplantation of a new prosthesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cost-utility ratio (ICER) | 12 months post-operative |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hélène SOAVELO | Contact | +33388116559 | helene.soavelo@chru-strasbourg.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Yves JENNY, PH | Strasbourg's University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Strasbourg | Recruiting | Strasbourg | 67000 | France |
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| Exchange of total hip or knee arthroplasty in two time | Procedure | Removal of the index implants in first time, extensive debridement, reimplantation of a new prosthesis in seconde time |
|
| 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 |
| ID | Term |
|---|---|
| D000088562 | Persistent Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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