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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| direct anterior approach with navigation assistance | Experimental | Patients treated surgically with total hip arthroplasty (direct anterior approach) with navigation assistance. |
|
| direct anterior approach without navigation assistance | Active Comparator | Patients treated surgically with total hip arthroplasty (direct anterior approach) without navigation assistance. |
|
| lateral direct approach with navigation assistance | Experimental | Patients treated surgically with total hip arthroplasty (lateral direct approach) with navigation assistance. |
|
| lateral direct approach without navigation assistance | Active Comparator | Patients treated surgically with total hip arthroplasty (lateral direct approach) without navigation assistance. |
|
| postero-lateral approach with navigation assistance | Experimental | Patients treated surgically with total hip arthroplasty (postero-lateral approach) with navigation assistance. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Velys hip navigation | Device | Computer assisted surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Legs dysmetria in millimeters calculated in anteroposterior x-rays | Legs lenght dysmetria in total hip replacement surgery | Intraoperatory |
| Measure | Description | Time Frame |
|---|---|---|
| Cup orientation in grade° calculated in anteroposterior x-rays | Cup orientation in total hip replacement surgery | Intraoperatory |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Federico Raggi, MD | Contact | 051 6366122 | +39 | federico.raggi@ior.it |
| Name | Affiliation | Role |
|---|---|---|
| Federico Raggi, MD | Isitituto Ortopedico Rizzoli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Recruiting | Bologna | 40136 | Italy |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| postero-lateral approach without navigation assistance | Active Comparator | Patients treated surgically with total hip arthroplasty (postero-lateral approach) without navigation assistance. |
|
| Standard of care | Procedure | surgery without navigation |
|
| D012216 |
| Rheumatic Diseases |