NCT06506201

Legs Dysmetria in Total Hip Replacement: Does Hip Approacches and Navigation Decrease the Risk?

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hip Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Velys hip navigation	Computer assisted surgery
PROCEDURE	Standard of care	surgery without navigation

Timeline

• Start date: 2024-05-13
• Primary completion: 2027-05-12
• Completion: 2027-05-12
• First posted: 2024-07-17
• Last updated: 2025-07-18

Locations

1 site across 1 country: Italy