An interventional study of Velys hip navigation and Standard of care in Hip Osteoarthritis, sponsored by Istituto Ortopedico Rizzoli. Recruiting at 1 site in Italy. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Treatment
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.
628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.
This study's planned enrollment of 136 is above the median of 90 across 450 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients treated surgically with total hip arthroplasty (direct anterior approach) with navigation assistance.
Device: Velys hip navigation
Patients treated surgically with total hip arthroplasty (direct anterior approach) without navigation assistance.
Procedure: Standard of care
Patients treated surgically with total hip arthroplasty (lateral direct approach) with navigation assistance.
Device: Velys hip navigation
Patients treated surgically with total hip arthroplasty (lateral direct approach) without navigation assistance.
Procedure: Standard of care
Patients treated surgically with total hip arthroplasty (postero-lateral approach) with navigation assistance.
Device: Velys hip navigation
Patients treated surgically with total hip arthroplasty (postero-lateral approach) without navigation assistance.
Procedure: Standard of care
Computer assisted surgery
surgery without navigation
Legs dysmetria in millimeters calculated in anteroposterior x-rays
Legs lenght dysmetria in total hip replacement surgery
Time frame: Intraoperatory
Cup orientation in grade° calculated in anteroposterior x-rays
Cup orientation in total hip replacement surgery
Time frame: Intraoperatory
Plan to share: No
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Istituto Ortopedico Rizzoli