Arthrosis, Avascular Necrosis of the Femoral Head, Congenital Hip Dysplasia, Rheumatoid Polyarthritis, Traumatic Arthritis
Conditions
Keywords
total hip arthroplasty, Quadra P anteverted, Medacta
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
Interventions
DEVICEQuadra 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
Sponsors
Medacta International SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the 10-year survival of the anteverted Quadra-P stem | 10 years | % survival rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess clinical performance | at 3 months, 1, 2, 5, 7 and 10 years. | Harris Hip score (HHS) (0 minimum-100 maximum) |
| Assess radiological performance | at pre-op, 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 |
| Assessing the patient's perception of the prosthetic joint | at 3 months and at 1, 2, 5, 7 and 10 years after surgery. | Forgotten Joint Score (FJS) (0 minimum-100 maximum) |
| Assessment of functional recovery | at pre-op, 3 months and at 1 year after surgery. | Assessment of functional recovery by gait analysis study |
| Collect the rate of complications | at pre-op, immediate post-op, 3 months, 1, 2, 5, 7 and 10 years. | Collect the rate of complications throughout the course of the study |
Countries
Italy
Outcome results
None listed