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Silver-Lined hips: new implant aims to stop repeat infections

NCT ID NCT06737809

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 is testing a special silver coating on hip implants to see if it can prevent infections after revision hip replacement surgery. The trial will enroll 268 adults who need a hip revision due to a chronic infection. Participants will receive either the coated implant or a standard one, and be monitored for 12 months to see if the coating reduces the chance of another infection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
silver-coated hip implant
What this could lead to
If it works, this could reduce the risk of repeat infections after hip replacement surgery, helping patients avoid further surgeries.
What could go wrong
This is a relatively small trial (268 people) and the coating may not prevent all infections. There could be side effects from the silver coating.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 268 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

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 \> 18 years * Patients indicated for unilateral cementless acetabular and hip stem revision due to chronic periprosthetic infection (according to EBJIS definition): single-stage or two-stage surgical procedure according to clinical standard at the clinical investigation site * According to the assessment of the clinical investigator, the subject is therapy compliant and able to attend the follow-up visits * ASA physical status I - III * Patient's signed written informed consent is available Exclusion Criteria: * Simultaneous participation in another interventional clinical trial (drugs or medical devices studies) * The investigational implant components (femoral and/or acetabular) are not suitable for the patient anatomy or bone defect * Patients who require plate osteosynthesis at the implantation site * Patients with an already implanted silver-coated device * Patients with immunodeficiency, i.e. patients currently receiving immunosuppressive therapy or patients with severe immunodeficiency requiring drug therapy * Patients currently undergoing cancer treatment, e.g. chemotherapy or radiation therapy * Severe soft tissue defects that require local or free flap procedure * Periprosthetic joint infections with evidence of fungal infection * Antibiotic suppression therapy * BMI \> 40 kg/m2 * Pregnancy, breast-feeding, or women of childbearing potential and not taking adequate contraceptive precautions * Known or patient reported hypersensitivity to silver or titanium * Patients held in a custodial setting * Patients in a relationship of dependence on the sponsor, the clinic or the investigator * Patients with contraindication for the investigational and comparator devices: * in case of secondary diseases influencing the function of the joint implant * in case of severe osteoporosis or osteomalacia * in case of poor bone quality and osseous malformations, diseases in the area of the implant fixation, which may primarily or subsequently affect the stability of the joint replacement anchorage * in case of non-regenerative bone conditions with lack of proximal femoral bone support and failure of defect union when use of prosthesis heads with neck length XXL is indicated

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Charité - Universitätsmedizin Berlin

    RECRUITING

    Berlin, 10117, Germany

  • Gruca Orthopedic and Trauma Teaching Hospital, Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP

    RECRUITING

    Otwock, 05-400, Poland