Actively Recruiting

Phase Not Applicable
Age: 50Years - 80Years
All Genders
NCT06506201

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

Led by Istituto Ortopedico Rizzoli · Updated on 2025-07-18

136

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 50Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 50 and 80 years
  • Signs and symptoms of hip osteoarthritis with pain intensity of at least 6 on a 0-10 scale in the previous week
  • Radiographic evidence of hip osteoarthritis Grade 3-4 according to Tonnis classification
Not Eligible

You will not qualify if you...

  • Unable to give consent
  • Previous surgery on the same hip
  • Lower limb surgery planned or performed in the past 12 months
  • Malignant tumors
  • Rheumatic diseases
  • Uncontrolled diabetes
  • Uncontrolled thyroid metabolic disorders
  • Abuse of alcohol, drugs, or medications
  • Body Mass Index greater than 35
  • Pregnant or fertile women
  • Pain intensity less than 6 on a 0-10 scale
  • Excessive deformity from acetabular or femoral head dysplasia
  • Previous total hip arthroplasty on the affected hip
  • Previous extensive surgery around the hip joint such as osteotomy or osteochondroplasty

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Istituto Ortopedico Rizzoli

Bologna, Italy, 40136

Actively Recruiting

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Research Team

F

Federico Raggi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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