Could a Double-Dose of antibiotics in bone cement prevent infections after hip surgery?
NCT ID NCT05164081
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 7,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- 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.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * 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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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