Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506201
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-17
Brief Title:
Legs Dysmetria in Total Hip Replacement Does Hip Approacches and Navigation Decrease the Risk
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Legs Dysmetria in Total Hip Replacement Does Hip Approacches and Navigation Decrease the Risk
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to collect clinical and radiological data from the case series of patients surgically treated with total hip arthroplasty at the Rizzoli Orthopaedic Institute
The primary objective is to evaluate in terms of safety and efficacy the reduction of legs dysmetria and proper acetabular cup inclination intraoperatively when comparing anterior direct lateral and postero-lateral hip approaches conducted via traditional or navigation-assisted surgery
The secondary objectives of the study are to evaluate by comparing navigation-assisted and non-navigation-assisted hip approaches intraoperatively the correct positioning of the prosthesis by analyzing the acetabular cup version surgical timing and number of intraoperative radiographs taken In addition the accuracy of preoperative planning will be assessed and a clinical evaluation performed during a follow-up of one year
The primary objective is to evaluate in terms of safety and efficacy the reduction of legs dysmetria and proper acetabular cup inclination intraoperatively when comparing anterior direct lateral and postero-lateral hip approaches conducted via traditional or navigation-assisted surgery
The secondary objectives of the study are to evaluate by comparing navigation-assisted and non-navigation-assisted hip approaches intraoperatively the correct positioning of the prosthesis by analyzing the acetabular cup version surgical timing and number of intraoperative radiographs taken In addition the accuracy of preoperative planning will be assessed and a clinical evaluation performed during a follow-up of one year
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None