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

NCT06506201 | Recruiting

• 1 other identifier: 0005971
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Legs dysmetria in millimeters calculated in anteroposterior x-rays

  Legs lenght dysmetria in total hip replacement surgery

  Intraoperatory

Secondary Outcomes (1)

• Cup orientation in grade° calculated in anteroposterior x-rays

  Intraoperatory

Study Arms (6)

direct anterior approach with navigation assistance

EXPERIMENTAL

Patients treated surgically with total hip arthroplasty (direct anterior approach) with navigation assistance.

Device: Velys hip navigation

direct anterior approach without navigation assistance

ACTIVE COMPARATOR

Patients treated surgically with total hip arthroplasty (direct anterior approach) without navigation assistance.

Procedure: Standard of care

lateral direct approach with navigation assistance

EXPERIMENTAL

Patients treated surgically with total hip arthroplasty (lateral direct approach) with navigation assistance.

Device: Velys hip navigation

lateral direct approach without navigation assistance

ACTIVE COMPARATOR

Patients treated surgically with total hip arthroplasty (lateral direct approach) without navigation assistance.

Procedure: Standard of care

postero-lateral approach with navigation assistance

EXPERIMENTAL

Patients treated surgically with total hip arthroplasty (postero-lateral approach) with navigation assistance.

Device: Velys hip navigation

postero-lateral approach without navigation assistance

ACTIVE COMPARATOR

Patients treated surgically with total hip arthroplasty (postero-lateral approach) without navigation assistance.

Procedure: Standard of care

Interventions

Velys hip navigation DEVICE

Computer assisted surgery

direct anterior approach with navigation assistance; lateral direct approach with navigation assistance; postero-lateral approach with navigation assistance

Standard of care PROCEDURE

surgery without navigation

direct anterior approach without navigation assistance; lateral direct approach without navigation assistance; postero-lateral approach without navigation assistance

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• Patients unable to express consent;
• Patients undergoing previous ipsilateral hip surgery;
• Patients undergoing lower limb surgery to be treated in the previous 12 months;
• Patients with malignant neoplasms;
• Patients with rheumatic diseases;
• Patients with uncontrolled diabetes;
• Patients with uncontrolled thyroid metabolic disorders;
• Patients abusing alcoholic beverages, drugs or medications;
• Body Mass Index \> 35;
• Pregnant and/or fertile women.
• Pain intensity less than 6 points in accordance with the visual analogic scale scale.
• Patients with the presence of excessive deformity resulting from acetabular or femoral head dysplasia
• Patients who have already undergone total hip arthroplasty surgery on the affected hip.
• Previous extensive surgery of the reference joint (osteotomy around the hip, open or arthroscopic osteochondroplasty for femoral-acetabular conflict).

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Federico Raggi, MD

  Isitituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Raggi, MD

CONTACT

051 6366122; federico.raggi@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: July 17, 2024
• Study Start: May 13, 2024
• Primary Completion (Estimated): May 12, 2027
• Study Completion (Estimated): May 12, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)