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NCT Number: NCT06506201

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.

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location status: Recruiting

Location contact

Federico Raggi, MD

CONTACT

[email protected]

0516366122 ext. +39

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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);

Exclusion criteria

  • 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).

Treatment and study plan

Velys hip navigation

Device

Computer assisted surgery

Standard of care

Procedure

surgery without navigation

Primary outcomes

  1. Legs dysmetria in millimeters calculated in anteroposterior x-rays

    Time frame: Intraoperatory

    Legs lenght dysmetria in total hip replacement surgery

Secondary outcomes

  1. Cup orientation in grade° calculated in anteroposterior x-rays

    Time frame: Intraoperatory

    Cup orientation in total hip replacement surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Federico Raggi, MD

CONTACT

[email protected]

051 6366122 ext. +39

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2024
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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