A Multi-centred, Post-market Clinical Follow-up Study of Synthetic Bone Graft Substitutes for Use in Orthopaedic and Spinal Applications.

Ceramisys Ltd7 sites in 1 country220 target enrollmentJune 13, 2019

ConditionsBone Deformity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bone Deformity
Sponsor: Ceramisys Ltd
Enrollment: 220
Locations: 7
Primary Endpoint: Primary endpoints will be successful radiographic bone repair.
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 13, 2019

End Date

June 2026

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Ceramisys Ltd

Responsible Party

Sponsor

Eligibility Criteria

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 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.