Ignite Creation Date:
2025-12-24 @ 12:10 PM
Ignite Modification Date:
2026-01-27 @ 1:10 PM
Study NCT ID:
NCT02651961
Status:
UNKNOWN
Last Update Posted:
2018-05-22
First Post:
2015-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cost-effectiveness Evaluation of One Stage Versus Two Stage Exchange for Chronically Infected Total Hip and Total Knee Prostheses
Sponsor:
University Hospital, Strasbourg, France
Organization:
Study Overview
Official Title:
Cost-effectiveness Evaluation of One Stage Versus Two Stage Exchange for Chronically Infected Total Hip and Total Knee Prostheses
Status:
UNKNOWN
Status Verified Date:
2018-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPRO
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.
The secondary criteria will be:
* quality of life;
* pain;
* persistence or recurrence of infection;
* occurrence of complications ;
* necessity for reoperation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: