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Recruiting

NCT Number: NCT04244942

CERAMENT™| Bone Void Filler Device Registry

A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.

Recruiting

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Key information

Conditions

Orthopedic Disorder Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HonorHealth, Scottsdale, Arizona, United States

Loading trial locations.

About this study

A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.

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 BVF 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

Exclusion criteria

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

Treatment and study plan

CERAMENT BVF

Device

CERAMENT BONE VOID FILLER is a synthetic biphasic bone graft substitute.

Primary outcomes

  1. Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

    Time frame: 12 months

    Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

  2. Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

    Time frame: 18 months

    Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

  3. Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

    Time frame: 12 months

    Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

  4. Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

    Time frame: 18 months

    Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

  5. Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

    Time frame: 12 and 18 months

    Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

  6. Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

    Time frame: 12 months

    Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

  7. adverse device events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

    Time frame: 18 months

    Adverse device events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

  8. SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

    Time frame: 12 months

    SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

  9. SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

    Time frame: 18 months

    SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

Secondary outcomes

  1. Radiological assessment at 6 and 12 months. Objective assessment of regeneration

    Time frame: 6 Months

    Bone healing

  2. Radiological assessment at 6 and 12 months. Objective assessment of regeneration

    Time frame: 12 Months

    Bone healing

  3. Pain VAS score

    Time frame: 6, 12, and 18 Months

    Pain assessment at 6,12, and 18 months

  4. EQ-5D-3L

    Time frame: 6, 12, and 18 months

    Functional assessment at 6, 12, and 18 months

Study contacts

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

Brian M Bartholdi

CONTACT

[email protected]

6178923927

Sponsors and collaborators

Lead sponsor

BONESUPPORT AB

Industry

Registry information

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Jan 28, 2020
Registry last updated
Sep 29, 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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