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One-and-done surgery for stubborn bone infections? new study puts bone filler to the test.

NCT ID NCT06555848

Disease control Sponsor: BONESUPPORT AB Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether a special bone filler called CERAMENT G can help treat chronic bone infections (osteomyelitis) in a single operation. About 128 adults with severe bone infections will receive the filler after infected bone is removed. Researchers will track infection clearance, bone healing, and complications over 3 years.

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

About 128 people

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

Started

Jun 2025

Expected to finish

Oct 2032

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.

Who is studied

Patients enrolled post-operatively with Osteomyelitis

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: Subjects meeting the following inclusion criteria are to be included in the analysis: 1. Patients receiving CERAMENT G subsequent to surgical excision of osteomyelitis, with Cierny-Mader classification grades III or IV, who require dead-space management of a bone defect following surgical debridement and excision of infection. 2. Symptoms for a minimum of six months with clinical and radiological features accompanied by at least one of the following: 1. the presence of a sinus 2. the presence of an abscess or intra-operative pus 3. the presence of positive supportive histology 4. two or more microbiological cultures with indistinguishable organisms (defined as cultures resulting in identification of the same microbe (e.g., Staph aureus) with similar antimicrobial sensitivity) Notes: In cases where cultures are negative, a patient will be included in the study only if there is positive supportive histology combined with the presence of a draining sinus or intra-operative pus. Infected non-unions will be included only if the bone loss is \< 1cm after debridement and excision of bone has been performed. Exclusion Criteria: The subject will be excluded from the study if: 1. Skeletal immaturity, defined as pre-operative/ screening radiology with evidence of incompletely fused physes. (determined by their previous x-rays which are taken as part of their admission, unrelated to the study) 2. Those unable to give informed consent for inclusion in the trial, or those not willing to be included 3. A known allergy or reaction to gentamicin or calcium sulfate 4. Treatment with a combination of different antibiotic-eluting bone graft substitutes 5. They have a segmental bone defect \> 1cm 6. Infection of the spine

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Conditions

The condition(s) this trial relates to.

osteomyelitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteomyelitis

How to take part

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

  1. The places running it

    1 site. 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

  • Bone Infection Unit, Nuffield Orthopaedic Centtre, Oxford University Hospitals, MHS

    RECRUITING

    Oxford, OX37HE, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.