The Medacta Quadra-P Anteverted Study (NCT05460715) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Medacta Quadra-P Anteverted Study
Italy300 participantsStarted 2021-07-30
Plain-language summary
This is a Post-Marketing Surveillance of Quadra-P anteverted stem prosthesis.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the 10-year survival of the anteverted Quadra-P stem