CERAMENT G Device Registry

J
Jan Szatkowski

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
1 participants needed
1 Location

Brief description of study

What is the purpose of this study?

This is an Observational Device Registry Study of CERAMENT G in normal use in accordance with the IFU. 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.

THIS STUDY IS ENROLLING BY INVITATION ONLY - The orthopaedic trauma team meets every morning to discuss the patients under orthopaedic care. Patients will be screened for study enrollment at that meeting. Patients with qualifying injuries will be flagged as potential candidates and further medical record review will be conducted by the study team. Patients will be approached in the hospital or outpatient clinic in a private room.

Detailed description of study

What will happen during the study?

This CIP outlines a multi-center, international, prospective, open-label, observational registry study on
the use of CERAMENT G for the treatment of bone voids and defects in adult humans. All enrolled
patients will be treated with CERAMENT G in accordance with standard clinical practice and according to
the Instructions for Use. This study is non-interventionist and does not call for any active deviation from
standard clinical pathways. 

SUMMARY 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.

Patients will be followed for 12 months following the point of their enrolment.

PRIMARY OUTCOMES:

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

SECONDARY OUTCOMES:

  • Bone healing at final follow-up
  • Pain and functional assessment at whatever follow-up times are usual for the specific clinical site, for example 6 & 12 months, if normally conducted
  • (Recurrence of) infection/revision surgery

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Bone injury, Chronic Osteomyelitis, Diabetic Foot Osteomyelitis, Fracture Related Infection
  • Age: 18 years - 100 years
  • Gender: All

Inclusion criteria:

  • 18 years and over (on the day of surgery)
  • receive CERAMENT|G as a component of their treatment at a participating, contracted center 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

Updated on 28 May 2025. Study ID: ORTHO-BONESUPPORT-CREAMENT-G, 25786
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting referrals by invitation only