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This is a Post-Marketing Surveillance of Quadra-P anteverted stem prosthesis.
The primary objective of this study is to evaluate the 10-year survival of the anteverted Quadra-P stem in patients operated for primary total hip arthroplasty, according to the inclusion criteria.
Secondary objectives:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadra P anteverted | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the 10-year survival of the anteverted Quadra-P stem | % survival rate | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Assess clinical performance | Harris Hip score (HHS) (0 minimum-100 maximum) | at 3 months, 1, 2, 5, 7 and 10 years. |
| Assess radiological performance | Assess radiological performance by standard radiographic examination performed before surgery, after surgery before discharge and during postoperative visits |
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Inclusion Criteria:
For the anatomical-functional subgroup:
- Adult subjects aged between 18 and 65 years at the date of surgery who have agreed to undergo the gait analysis study.
Exclusion Criteria:
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The aim of the study is to monitor the clinical performance and survival of the Quadra-P antevert stem when used according to its indications. Since patients are not subjected to additional risks or procedures compared to standard practice, the total number of patients was defined on the basis of the surgeon's potential and observational studies of the same type already published in the literature.
For the anatomical-functional subgroup, a sample size was defined to verify 10% speed increases between pre- and postoperative. Considering α = 5% and Power = 90%, 30 patients will be required.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Franco Scalabrino | Messina | Messina | Italy |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D006618 | Hip Dislocation, Congenital |
| D005271 | Femur Head Necrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| at pre-op, 3 months, 1, 2, 5, 7 and 10 years. |
| Assessing the patient's perception of the prosthetic joint | Forgotten Joint Score (FJS) (0 minimum-100 maximum) | at 3 months and at 1, 2, 5, 7 and 10 years after surgery. |
| Assessment of functional recovery | Assessment of functional recovery by gait analysis study | at pre-op, 3 months and at 1 year after surgery. |
| Collect the rate of complications | Collect the rate of complications throughout the course of the study | at pre-op, immediate post-op, 3 months, 1, 2, 5, 7 and 10 years. |
| D000082602 |
| Developmental Dysplasia of the Hip |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |