Blood test may predict need for hip revision surgery

NCT ID NCT02208271

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Aug 2020

Lead sponsor

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

18 years and older

Sex

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

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

  • OrthoCarolina

    Charlotte, North Carolina, 28207, United States

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