An observational study in Arthrosis, Traumatic Arthritis and Rheumatoid Polyarthritis, sponsored by Medacta International SA. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by Medacta International SA · Observational
This is a Post-Marketing Surveillance of Quadra-P anteverted stem prosthesis.
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:
4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 792 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Medacta International SA is the lead sponsor of 46 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The aim of the study is to monitor the clinical performance and survival of the Quadra-P antevert stem when used according to its indications. Since patients are not subjected to additional risks or procedures compared to standard practice, the total number of patients was defined on the basis of the surgeon's potential and observational studies of the same type already published in the literature.
For the anatomical-functional subgroup, a sample size was defined to verify 10% speed increases between pre- and postoperative. Considering α = 5% and Power = 90%, 30 patients will be required.
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:
* 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
Evaluate the 10-year survival of the anteverted Quadra-P stem
% survival rate
Time frame: 10 years
Assess clinical performance
Harris Hip score (HHS) (0 minimum-100 maximum)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: at pre-op, immediate post-op, 3 months, 1, 2, 5, 7 and 10 years.
Plan to share: No
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This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Medacta International SA