The Medacta Quadra-P Anteverted Study

Study Overview
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Brief Summary
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This is a Post-Marketing Surveillance of Quadra-P anteverted stem prosthesis.

Detailed Description
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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: To assess clinical performance by Harris Hip score collected during preoperative and postoperative visits at 3 months, 1, 2, 5, 7 and 10 years. Assess radiological performance by standard radiographic examination performed preoperatively, postoperatively before discharge and during postoperative visits at 3 months, 1, 2, 5, 7 and 10 years. Assessing the patient's perception of the prosthetic joint by means of FJS questionnaire collected during the preoperative visit and postoperative visits at 3 months and at 1, 2, 5, 7 and 10 years after surgery. Assessment of functional recovery by gait analysis study Collect the rate of complications throughout the course of the study

Official Title
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Prospective Multicentre Study to Evaluate the Long-term Performance of Anteverted Femoral Stems in Total Hip Arthroplasty

Conditions
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Arthrosis, Traumatic Arthritis, Rheumatoid Polyarthritis, Congenital Hip Dysplasia, Avascular Necrosis of the Femoral Head

Intervention / Treatment
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* Device: Quadra P anteverted


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects suffering from primary hip arthrosis, post-traumatic arthrosis, dysplasia or avascular necrosis of the femoral head, rheumatoid arthritis Adult subjects between 18 and 75 years of age on the date of surgery Subjects eligible for primary total hip arthroplasty surgery for whom the anterior Quadra-P femoral component will be implanted according to the indications for use of the implant Subjects who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to surgery. 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: Subjects with acute or chronic infection Subjects with a femoral neck fracture Subjects with mental conditions that impair their ability to consent to the study, to complete required questionnaires or to complete follow-up visits Subjects with severe deformities, at the discretion of the surgeon Subjects with metabolic disorders that may involve bone metabolism for which an uncemented implant would be contraindicated Subjects with muscular atrophy or neuromuscular diseases Subjects allergic to the materials used during surgery Subjects unable or unwilling to provide consent for participation in the study Any other condition not mentioned in the inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Quadra P anteverted|Assess clinical performance by Harris Hip score collected during preoperative and postoperative visits at 3 months, 1, 2, 5, 7 and 10 years. Assess radiological performance by standard radiographic examination performed before surgery, after surgery before discharge and during postoperative visits at 3 months, 1, 2, 5, 7 and 10 years. Assessing the patient's perception of the prosthetic joint by means of FJS questionnaire collected during the preoperative visit and postoperative visits at 3 months and at 1, 2, 5, 7 and 10 years after surgery. Assessment of functional recovery by gait analysis study Collect the rate of complications throughout the course of the study|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the 10-year survival of the anteverted Quadra-P stem | % survival rate | 10 years | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total hip arthroplasty, Quadra P anteverted, Medacta