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Could a Double-Dose of antibiotics in bone cement prevent infections after hip surgery?

NCT ID NCT05164081

What the study statuses mean

This study's is highlighted.

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two types of antibiotic-loaded bone cement used during hip fracture surgery to see which better prevents joint infections. About 7000 patients aged 60 and older with displaced femoral neck fractures will be included. Hospitals are randomly assigned to use either a single antibiotic (gentamicin) or a dual antibiotic (gentamicin plus clindamycin) cement for two years, then switch to the other for another two years. The main goal is to see if the dual-antibiotic cement reduces infection rates within one year after surgery.

What this could mean

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

Active substance
antibiotic-loaded bone cement (gentamicin with or without clindamycin)
What this could lead to
If it works, this could point toward a better way to prevent serious joint infections after hip fracture surgery, potentially reducing reoperations and deaths.
What could go wrong
This is a large trial, but results may not apply to all patients or hospitals. Adding another antibiotic could also increase side effects or antibiotic resistance.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 7,000 people

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

Started

Jan 2022

Expected to finish

Jan 2027

An estimate. End dates often move.

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.

Ages

60 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: * Age ≥60 years * Diagnosis: displaced femoral neck fracture type AO 31-B2 or B3/Garden type 3 or 4 * Eligible for HA according to local guidelines and routines Exclusion Criteria: * Previous inclusion of contralateral hip in the present study * Pathological or stress fracture of the femoral neck, or fracture adjacent to a previous ipsilateral hip implant * Unavailability of both interventions for a study participant (e.g., sensitivity to any of the components in the bone cement) * Patients that have actively marked their hospital charts with an added privacy notice

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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

  • Umeå University Hospital

    Umeå, Västerbotten County, Sweden

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