Clinical trial NCT03570606: Clinical Study of Bone Graft Substitutes in Orthopaedic and Spinal Applications.
Official title: A Multi-centred, Post-market Clinical Follow-up Study of Synthetic Bone Graft Substitutes for Use in Orthopaedic and Spinal Applications.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bone Deformity
Lead sponsor: Ceramisys Ltd
Sponsor class: INDUSTRY
First posted: 2018-06-27
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: male or female 18-80 meeting the inclusion criteria, provided no exclusion criteria are met:

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.


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.

Primary outcomes:
measure: Primary endpoints will be successful radiographic bone repair.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Doncaster
country: United Kingdom
facility: Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
city: Birmingham
country: United Kingdom
facility: Sandwell and West Birmingham NHS Trust of City Hospital
city: Birmingham
country: United Kingdom
facility: The Royal Orthopaedic Hospital NHS Foundation Trust
city: North Shields
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
city: Taunton
country: United Kingdom
facility: Taunton and Somerset NHS Foundation Trust
Study officials:
References: