Overview
This is a Post-Marketing Surveillance of Quadra-P anteverted stem prosthesis.
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
Eligibility
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