Menu
Recruiting NCT04244942

CERAMENT™| Bone Void Filler Device Registry

— Observational Orthopedic Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CERAMENT BVF.
Who it may be relevant to
Registry conditions: Orthopedic Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed description

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

Interventions

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

Primary outcome measures

  • 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 [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 [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 [Time frame: 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 [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 [Time frame: 12 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 [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 [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 [Time frame: 18 months]
Secondary outcome measures (4)
  • Radiological assessment at 6 and 12 months. Objective assessment of regeneration [Time frame: 6 Months]
  • Radiological assessment at 6 and 12 months. Objective assessment of regeneration [Time frame: 12 Months]
  • Pain VAS score [Time frame: 6, 12, and 18 Months]
  • EQ-5D-3L [Time frame: 6, 12, and 18 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 13 centers
  • HonorHealth — Scottsdale
  • Golden Orthopedic Knee, Hip, Shoulder and Foot Center — Boca Raton
  • Sports and Orthopedic Center — Boca Raton
  • Dr. Peter Merkle — Pompano Beach
  • Florida Orthopedic Foot & Ankle Center — Sarasota
  • James Cottom — Sarasota
  • Indiana University — Indianapolis
  • OrthoIndy — Indianapolis
  • … and 5 more centers

Identifiers

NCT: NCT04244942 · S025/2018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗