Clinical Study of Bone Graft Substitutes in Orthopaedic and Spinal Applications.

Last updated: April 2, 2025
Sponsor: Ceramisys Ltd
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Holoprosencephaly

Birth Defects

Treatment

bone graft substitute

Clinical Study ID

NCT03570606
ROSA01
  • Ages 18-80
  • All Genders

Study Summary

This is an observational, prospective, non-randomised, multi-centred post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical setting in long bone and extremity defects and in spinal fusion procedures.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Long Bone and Extremity Indications: patients requiring bone grafting after post-traumatic or surgically created bone defects afflicting the long bones and extremities.

Spine Indication: patients with degenerative disc disease or trauma who require spinal fusion of 1 or more vertebral bodies and where conservative treatment has been unsuccessful.

Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center;

Exclusion

Exclusion Criteria:

Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.

Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion); The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.

Study Design

Total Participants: 220
Treatment Group(s): 1
Primary Treatment: bone graft substitute
Phase:
Study Start date:
June 13, 2019
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust

    Doncaster, South Yorkshire DN2 5LT
    United Kingdom

    Site Not Available

  • Sandwell and West Birmingham NHS Trust of City Hospital

    Birmingham,
    United Kingdom

    Site Not Available

  • The Royal Orthopaedic Hospital NHS Foundation Trust

    Birmingham,
    United Kingdom

    Site Not Available

  • Northumbria Healthcare NHS Foundation Trust

    North Shields,
    United Kingdom

    Site Not Available

  • Salford Royal NHS Foundation Trust

    Salford,
    United Kingdom

    Site Not Available

  • University Hospitals of North Midlands NHS Trust

    Stoke-on-Trent,
    United Kingdom

    Site Not Available

  • Taunton and Somerset NHS Foundation Trust

    Taunton,
    United Kingdom

    Site Not Available

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