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Recruiting

NCT Number: NCT06010433

CERAMENT G Device Registry

This is an Observational Device Registry Study of CERAMENT|G in normal use in accordance with the IFU. It will run for a period of three years from enrolment of the first patient into the Study at each Site, before being subject to review. A Device Registry is a form of observational study that concerns the performance of a device in normal use. It is intended to collect data that is reflective of 'real world' device performance.

Recruiting

Interested in participating?

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Key information

Conditions

Chronic Osteomyelitis Diabetic Foot Osteomyelitis Fracture Related Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North Park Podiatry, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years and over (on the day of surgery)
  • receive CERAMENT|G as a component of their treatment at a participating, contracted centre or healthcare provider, in accordance with the IFU for the implanted product
  • In receipt of patient information leaflet and have signed appropriately designed informed consent form.

Exclusion criteria

  • Any exclusion criteria as per IFU for CERAMENT|G
  • Any off-label use

Treatment and study plan

CERAMENT G

Device
  • Primary mode of action is to be a resorbable ceramic bone graft substitute intended to fill gaps and voids in the skeleton system to promote bone healing. CERAMENT ™|G provides a void/gap filler that during the surgical procedure can augment hardware and bone alignments.
  • Secondary mode of action is to prevent colonization of Gentamicin sensitive microorganisms in order to protect bone healing.

Primary outcomes

  1. Primary Outcomes

    Time frame: 12 months

    • Device safety - any unexpected device performance, complaints, adverse events, adverse device effects, SAEs throughout study period.

Secondary outcomes

  1. Secondary Outcome

    Time frame: 12 months

    Bone healing at final follow-up

  2. Secondary Outcome

    Time frame: 6 and 12 months

    Pain and functional assessment at whatever follow-up times are usual for the specific clinical site, for example 6 & 12 months, if normally conducted

  3. Secondary Outcome

    Time frame: 12 months

    (Recurrence of) infection/revision surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Brian M Bartholdi

CONTACT

[email protected]

16178923927

Sponsors and collaborators

Lead sponsor

BONESUPPORT AB

Industry

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Aug 24, 2023
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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