Prospective Multicentre Study to Evaluate the Long-term Performance of Anteverted Femoral Stems in Total Hip Arthroplasty
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arthrosis
- Sponsor
- Medacta International SA
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Evaluate the 10-year survival of the anteverted Quadra-P stem
- Status
- Active, not recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
This is a Post-Marketing Surveillance of Quadra-P anteverted stem prosthesis.
Detailed Description
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Evaluate the 10-year survival of the anteverted Quadra-P stem
Time Frame: 10 years
% survival rate
Secondary Outcomes
- Assessing the patient's perception of the prosthetic joint(at 3 months and at 1, 2, 5, 7 and 10 years after surgery.)
- Collect the rate of complications(at pre-op, immediate post-op, 3 months, 1, 2, 5, 7 and 10 years.)
- Assess clinical performance(at 3 months, 1, 2, 5, 7 and 10 years.)
- Assessment of functional recovery(at pre-op, 3 months and at 1 year after surgery.)
- Assess radiological performance(at pre-op, 3 months, 1, 2, 5, 7 and 10 years.)