Hip OsteoarthritisNCT06506201
Legs Dysmetria in Total Hip Replacement: Does Hip Approacches and Navigation Decrease the Risk?
A study testing Velys hip navigation in people with Hip Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Velys hip navigation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteItaly
- Study dates
- 13 May 2024to 12 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Rizzoli
Bologna, 40136
Federico Raggi, MD, 0516366122 ext. +39, federico.raggi@ior.it
About this study
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.
- Conditions
- Hip Osteoarthritis
- Being tested
- Velys hip navigation, Standard of care
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Velys hip navigationDevice
Computer assisted surgery
Standard of careProcedure or surgery
surgery without navigation
| Study group | Role | What they receive |
|---|---|---|
| direct anterior approach with navigation assistance | Experimental | Patients treated surgically with total hip arthroplasty (direct anterior approach) with navigation assistance. Receives: Device: Velys hip navigation |
| direct anterior approach without navigation assistance | Active comparator | Patients treated surgically with total hip arthroplasty (direct anterior approach) without navigation assistance. Receives: Procedure: Standard of care |
| lateral direct approach with navigation assistance | Experimental | Patients treated surgically with total hip arthroplasty (lateral direct approach) with navigation assistance. Receives: Device: Velys hip navigation |
| lateral direct approach without navigation assistance | Active comparator | Patients treated surgically with total hip arthroplasty (lateral direct approach) without navigation assistance. Receives: Procedure: Standard of care |
| postero-lateral approach with navigation assistance | Experimental | Patients treated surgically with total hip arthroplasty (postero-lateral approach) with navigation assistance. Receives: Device: Velys hip navigation |
| postero-lateral approach without navigation assistance | Active comparator | Patients treated surgically with total hip arthroplasty (postero-lateral approach) without navigation assistance. Receives: Procedure: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Legs dysmetria in millimeters calculated in anteroposterior x-rays
Legs lenght dysmetria in total hip replacement surgery
Measured: Intraoperatory
Secondary outcomes (1)
Cup orientation in grade° calculated in anteroposterior x-rays
Cup orientation in total hip replacement surgery
Measured: Intraoperatory
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start13 May 2024
- Primary completion12 May 2027 (estimated)
- Study completion12 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Federico Raggi, MD, Principal investigator, Isitituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506201
- Sponsor's protocol ID
- 0005971
- Status last verified
- Jul 2025
- First submitted
- 17 Jun 2024
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Legs Dysmetria in Total Hip Replacement: Does Hip Approacches and Navigation Decrease the Risk?
- ClinicalTrials.gov ID
- NCT06506201
- Acronym / sponsor ID
- 0005971
- Conditions
- Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 13 May 2024 (actual)
- Primary completion
- 12 May 2027 (estimated)
- Study completion
- 12 May 2027 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| direct anterior approach with navigation assistance | Experimental | Device: Velys hip navigationPatients treated surgically with total hip arthroplasty (direct anterior approach) with navigation assistance. |
| direct anterior approach without navigation assistance | Active comparator | Procedure: Standard of carePatients treated surgically with total hip arthroplasty (direct anterior approach) without navigation assistance. |
| lateral direct approach with navigation assistance | Experimental | Device: Velys hip navigationPatients treated surgically with total hip arthroplasty (lateral direct approach) with navigation assistance. |
| lateral direct approach without navigation assistance | Active comparator | Procedure: Standard of carePatients treated surgically with total hip arthroplasty (lateral direct approach) without navigation assistance. |
| postero-lateral approach with navigation assistance | Experimental | Device: Velys hip navigationPatients treated surgically with total hip arthroplasty (postero-lateral approach) with navigation assistance. |
| postero-lateral approach without navigation assistance | Active comparator | Procedure: Standard of carePatients treated surgically with total hip arthroplasty (postero-lateral approach) without navigation assistance. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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);
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Velys hip navigationComputer assisted surgery | Device | direct anterior approach with navigation assistance, lateral direct approach with navigation assistance, postero-lateral approach with navigation assistance |
| Standard of caresurgery without navigation | Procedure or surgery | direct anterior approach without navigation assistance, lateral direct approach without navigation assistance, postero-lateral approach without navigation assistance |
Primary outcome
Legs dysmetria in millimeters calculated in anteroposterior x-rays
Time frame: Intraoperatory
Legs lenght dysmetria in total hip replacement surgery
1 secondary outcome
Cup orientation in grade° calculated in anteroposterior x-rays
Time frame: Intraoperatory
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Hip Osteoarthritis
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Federico Raggi, MD principal investigator
Isitituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Velys hip navigation in people with Hip Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federico Raggi, MD (051 6366122 ext. +39, federico.raggi@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Legs dysmetria in millimeters calculated in anteroposterior x-rays (time frame: Intraoperatory). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.