Legs Dysmetria in Total Hip Replacement: Does Hip Approacches and Navigation Decrease the Risk?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Velys hip navigation, Standard of care.
- Who it may be relevant to
- Registry conditions: Hip Osteoarthritis. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Velys hip navigation
Computer assisted surgery - Procedure Standard of care
surgery without navigation
Primary outcome measures
- Legs dysmetria in millimeters calculated in anteroposterior x-rays [Time frame: Intraoperatory]
Secondary outcome measures (1)
- Cup orientation in grade° calculated in anteroposterior x-rays [Time frame: Intraoperatory]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Istituto Ortopedico Rizzoli — Bologna
Identifiers
NCT: NCT06506201 · 0005971