Trials / Active Not Recruiting
Active Not RecruitingNCT05460715
The Medacta Quadra-P Anteverted Study
Prospective Multicentre Study to Evaluate the Long-term Performance of Anteverted Femoral Stems in Total Hip Arthroplasty
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Medacta International SA · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Conditions
- Arthrosis
- Traumatic Arthritis
- Rheumatoid Polyarthritis
- Congenital Hip Dysplasia
- Avascular Necrosis of the Femoral Head
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-07-30
- Primary completion
- 2032-07-01
- Completion
- 2032-07-01
- First posted
- 2022-07-15
- Last updated
- 2025-09-29
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT05460715. Inclusion in this directory is not an endorsement.