NCT06506201 Legs Dysmetria in Total Hip Replacement: Does Hip Approacches and Navigation Decrease the Risk?
| NCT ID | NCT06506201 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Hip Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2024-05-13 |
| Primary Completion | 2027-05-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 136 participants in total. It began in 2024-05-13 with a primary completion date of 2027-05-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
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).
Contact & Investigator
Federico Raggi, MD
PRINCIPAL INVESTIGATOR
Isitituto Ortopedico Rizzoli
Frequently Asked Questions
Who can join the NCT06506201 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Hip Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06506201 currently recruiting?
Yes, NCT06506201 is actively recruiting participants. Contact the research team at federico.raggi@ior.it for enrollment information.
Where is the NCT06506201 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06506201 clinical trial?
NCT06506201 is sponsored by Istituto Ortopedico Rizzoli. The principal investigator is Federico Raggi, MD at Isitituto Ortopedico Rizzoli. The trial plans to enroll 136 participants.