Blood test may predict need for hip revision surgery
NCT ID NCT02208271
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to develop a biomarker test using blood or joint fluid to detect tissue damage (necrosis) caused by metal-on-metal hip implants. Researchers planned to enroll 174 patients, including those needing revision surgery and a control group. The goal was to see if the test could accurately identify who needs surgery, but the study was terminated early.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could provide a simple test to help doctors decide when revision surgery is needed for metal-on-metal hip implants.
- What could go wrong
- The study was terminated early, so results are limited. The test is still experimental and not yet proven to work in routine care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
174 people
The number who actually took part.
- Started
-
Aug 2014
- Finished
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Aug 2020
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
A convenience sample of a total of 100 hip patients will be enrolled at orthopedic clinics.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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OrthoCarolina
Charlotte, North Carolina, 28207, United States
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