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CERAMENT G Device Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06010433
Recruitment Status : Not yet recruiting
First Posted : August 24, 2023
Last Update Posted : August 24, 2023
Sponsor:
Information provided by (Responsible Party):
BONESUPPORT AB

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Chronic Osteomyelitis Fracture Related Infection Diabetic Foot Osteomyelitis Device: CERAMENT G

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: CERAMENT G Device Registry
Estimated Study Start Date : September 22, 2023
Estimated Primary Completion Date : September 22, 2028
Estimated Study Completion Date : September 22, 2028

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: CERAMENT G
    • 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.

Outcome Measures
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Primary Outcome Measures :
  1. Primary Outcomes [ Time Frame: 12 months ]
    • Device safety - any unexpected device performance, complaints, adverse events, adverse device effects, SAEs throughout study period.


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The racial, gender and ethnic characteristics of the individuals approached for participation in this Observational Registry Study shall reflect the demographics of patients that would ordinarily receive CERAMENT|G for the treatment of their condition at the designated investigative centres. No individuals shall be excluded from participation in the Observational Registry Study based on race, nationality, ethnicity, gender, or sexuality
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06010433


Contacts
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Contact: Brian M Bartholdi 16178923927 brian.bartholdi@bonesupport.com

Sponsors and Collaborators
BONESUPPORT AB
More Information
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Responsible Party: BONESUPPORT AB
ClinicalTrials.gov Identifier: NCT06010433    
Other Study ID Numbers: S050/2018
First Posted: August 24, 2023    Key Record Dates
Last Update Posted: August 24, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Osteomyelitis
Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Bone Diseases, Infectious
Infections
Bone Diseases
Musculoskeletal Diseases