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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• Age between 50 and 80 years;

• Signs and symptoms of hip osteoarthritis (pain intensity of at least 6 points of visual analogic scale pain - 0-10 scale in the previous week);

• Radiographic signs of hip osteoarthritis (Grade 3-4 according to Tonnis classification);

Locations
Other Locations
Italy
Istituto Ortopedico Rizzoli
RECRUITING
Bologna
Contact Information
Primary
Federico Raggi, MD
federico.raggi@ior.it
051 6366122
Time Frame
Start Date: 2024-05-13
Estimated Completion Date: 2027-05-12
Participants
Target number of participants: 136
Treatments
Experimental: direct anterior approach with navigation assistance
Patients treated surgically with total hip arthroplasty (direct anterior approach) with navigation assistance.
Active_comparator: direct anterior approach without navigation assistance
Patients treated surgically with total hip arthroplasty (direct anterior approach) without navigation assistance.
Experimental: lateral direct approach with navigation assistance
Patients treated surgically with total hip arthroplasty (lateral direct approach) with navigation assistance.
Active_comparator: lateral direct approach without navigation assistance
Patients treated surgically with total hip arthroplasty (lateral direct approach) without navigation assistance.
Experimental: postero-lateral approach with navigation assistance
Patients treated surgically with total hip arthroplasty (postero-lateral approach) with navigation assistance.
Active_comparator: postero-lateral approach without navigation assistance
Patients treated surgically with total hip arthroplasty (postero-lateral approach) without navigation assistance.
Sponsors
Leads: Istituto Ortopedico Rizzoli

This content was sourced from clinicaltrials.gov