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

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Device: Velys hip navigation; Procedure: Standard of care

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Federico Raggi, MD; Phone Number: +39 051 6366122; Email: federico.raggi@ior.it

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • Istituto Ortopedico Rizzoli
    • Contact: Federico Raggi, MD; Phone Number: +39 0516366122; Email: federico.raggi@ior.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age between 50 and 80 years;
2. 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);
3. Radiographic signs of hip osteoarthritis (Grade 3-4 according to Tonnis classification);

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: direct anterior approach with navigation assistance; Patients treated surgically with total hip arthroplasty (direct anterior approach) with navigation assistance.	Device: Velys hip navigation; Computer assisted surgery
Active Comparator: direct anterior approach without navigation assistance; Patients treated surgically with total hip arthroplasty (direct anterior approach) without navigation assistance.	Procedure: Standard of care; surgery without navigation
Experimental: lateral direct approach with navigation assistance; Patients treated surgically with total hip arthroplasty (lateral direct approach) with navigation assistance.	Device: Velys hip navigation; Computer assisted surgery
Active Comparator: lateral direct approach without navigation assistance; Patients treated surgically with total hip arthroplasty (lateral direct approach) without navigation assistance.	Procedure: Standard of care; surgery without navigation
Experimental: postero-lateral approach with navigation assistance; Patients treated surgically with total hip arthroplasty (postero-lateral approach) with navigation assistance.	Device: Velys hip navigation; Computer assisted surgery
Active Comparator: postero-lateral approach without navigation assistance; Patients treated surgically with total hip arthroplasty (postero-lateral approach) without navigation assistance.	Procedure: Standard of care; surgery without navigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Legs dysmetria in millimeters calculated in anteroposterior x-rays	Legs lenght dysmetria in total hip replacement surgery	Intraoperatory

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cup orientation in grade° calculated in anteroposterior x-rays	Cup orientation in total hip replacement surgery	Intraoperatory

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Investigators: Principal Investigator: Federico Raggi, MD, Isitituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2024
• Primary Completion (Estimated): May 12, 2027
• Study Completion (Estimated): May 12, 2027

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 0005971

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes