Evaluating hip approaches and navigation in total hip replacement for leg length discrepancies

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

This study is testing different surgical methods for hip replacement to see which one helps patients with leg length differences feel better and have better results after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 136 (estimated)
• Ages: 50 Years to 80 Years
• Sex: All
• Sponsor: Istituto Ortopedico Rizzoli (Academic / other)
• Locations: 1 site (Bologna)
• Trial ID: NCT06506201 on ClinicalTrials.gov

What this trial studies

This study aims to collect clinical and radiological data from patients undergoing total hip arthroplasty at the Rizzoli Orthopaedic Institute. It will compare the safety and efficacy of different surgical approaches—anterior, direct lateral, and postero-lateral—using both traditional and navigation-assisted techniques. The primary focus is on reducing leg dysmetria and ensuring proper acetabular cup inclination during surgery. Secondary objectives include assessing prosthesis positioning, surgical timing, and the accuracy of preoperative planning over a one-year follow-up period.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 to 80 with significant hip osteoarthritis and pain.

Not a fit: Patients with prior hip surgeries, certain medical conditions, or those with a lower pain intensity may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing total hip replacement.

How similar studies have performed: Previous studies have shown promising results with navigation-assisted techniques in orthopedic surgeries, suggesting potential for success in this approach.

Eligibility criteria

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).

Where this trial is running

Bologna

• Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)

Study contacts

• Principal investigator: Federico Raggi, MD — Isitituto Ortopedico Rizzoli
• Study coordinator: Federico Raggi, MD

Conditions Hip Osteoarthritis