A Validated Necrosis Assay to Determine the Need for Revision Surgery in Metal-on-metal Total Hip… (NCT02208271) | Clinical Trial Compass
TerminatedNot Applicable
A Validated Necrosis Assay to Determine the Need for Revision Surgery in Metal-on-metal Total Hip Arthroplasty
Stopped: The lab contracted by the site to complete specimen analysis backed out on their agreement to do so. At this time it is not feasible for a new contract to be entered into by the site.
United States174 participantsStarted 2014-08-04
Plain-language summary
The purpose of the study is to develop a biomarker assay to be used as a diagnostic tool for adverse local tissue reaction, or tissue necrosis, in a metal on metal total hip replacement.
A convenience sample of a total of 100 hip patients will be enrolled: 50 metal-on-metal revision hips, 25 metal-on-poly revision hips, and 25 pre-operative total hips (no implant, control group) will be enrolled. Preoperative blood serum samples and intraoperative synovial fluid will be obtained from all hips and used for biomarker testing. Additionally, intraoperative assessment of tissue necrosis will be assessed.
Who can participate
Age range
18 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:
* Patients presenting for a metal on metal hip revision who have cobalt and chromium metal ion levels tested within 6 months of the date of the planned revision surgery.
* Patients presenting for a metal on poly hip revision
* Revision hip patients must be greater than one year postoperative
* The diagnosis at the time of the index, or primary, hip replacement was osteoarthritis.
* Patients who have hip osteoarthritis but have not had a total hip surgery (control)
Exclusion Criteria:
* Patients presenting for a metal on metal hip revision who have cobalt and chromium metal ion levels tested \>6 months of the date of the planned revision
* Patients with a total hip on the contralateral side.
* Patients with a prior history of periprosthetic infection
* Revision cases where the diagnosis at the time of the index, or primary, hip replacement was not osteoarthritis.
* Prisoners
* Patients not willing to consent for the proposed treatment
* Patients with an altered mental status
* Active, concurrent metastatic infection
* Active, superficial infection
* Patients presenting for a metal on poly hip revision to treat trunionosis
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
The number of patients with serum and synovial fluid biomarkers
Timeframe: participants will be followed for the duration of their hospital stay, an expected average of 2 hours