Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing… (NCT03681639) | Clinical Trial Compass
CompletedNot Applicable
Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component
Germany45 participantsStarted 2009-08-01
Plain-language summary
The Zimmer Hip Resurfacing System Post-Market Clinical Follow-up study will examine the safety and efficacy of this device in the young and/or active patient with advanced hip disease.
Who can participate
Age range
18 Years – 65 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
. Patient selection without bias to race or gender.
. Patient is ≥ 18 and ≤ 65 years of age.
. Female patients only, if
. Actively practicing a contraceptive method, or
. Surgically sterilized, or
. Post-menopausal
. Pre-operative Harris Hip Score ≤ 70.
. Primary surgical hip candidate, suffering from hip pain and/or disability due to degenerative joint disease (inflammatory or non-inflammatory), based on physical examination and history, which may include the following diagnosis:
Exclusion criteria
. Patient has an acute, chronic, local or systemic infection.
. Patient is skeletally immature.
. Patient is known to be pregnant.
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.
. Patient has a severe muscular, neural or vascular disease that endangers the involved extremity.
. Patient has an insufficient acetabular or femoral bone stock in which good anchorage of the implants are unlikely or impossible, including, but not limited to:
. patient with severe osteopenia,
. patients with a family history of severe osteoporosis or osteopenia,
. patients with osteonecrosis or avascular necrosis (AVN) with \>50% involvement of the femoral head (regardless of FICAT grade), or