Clinical Study of Bone Graft Substitutes in Orthopaedic and Spinal Applications.
NCT ID: NCT03570606
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
220 participants
OBSERVATIONAL
2019-06-13
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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HA Paste in Spine
Evaluation of HA Paste in spinal fusion procedures
o Spinal cage filling
bone graft substitute
orthopaedic or spine bony defects
HA Paste in long bone & extremities
Evaluation of HA Paste in long bone and extremity group:
* Filling bone defects after cyst removal
* Filling distal radius fractures
* Filling defects such as tibial plateau fractures
* Filling defects created by osteotomy procedures
bone graft substitute
orthopaedic or spine bony defects
Granulated Paste in Spine
Evaluation of Granulated Paste in spinal fusion procedures
o Spinal cage filling
bone graft substitute
orthopaedic or spine bony defects
Granulated Paste in long bone & extremities
Evaluation of Granulated Paste in long bone and extremity group:
* Filling bone defects after cyst removal
* Filling distal radius fractures
* Filling defects such as tibial plateau fractures
* Filling defects created by osteotomy procedures
bone graft substitute
orthopaedic or spine bony defects
Granules in Spine
Evaluation of Granules in spinal fusion procedures
o Spinal cage filling
bone graft substitute
orthopaedic or spine bony defects
Granules in long bone & extremities
Evaluation of Granules in long bone and extremity group:
* Filling bone defects after cyst removal
* Filling distal radius fractures
* Filling defects such as tibial plateau fractures
* Filling defects created by osteotomy procedures
bone graft substitute
orthopaedic or spine bony defects
Block in long bone & extremities
Evaluation of Blocks in long bone and extremity group:
o High tibial osteotomies with fixation
bone graft substitute
orthopaedic or spine bony defects
Interventions
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bone graft substitute
orthopaedic or spine bony defects
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Ceramisys Ltd
INDUSTRY
Responsible Party
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Locations
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Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster, South Yorkshire, United Kingdom
Sandwell and West Birmingham NHS Trust of City Hospital
Birmingham, , United Kingdom
The Royal Orthopaedic Hospital NHS Foundation Trust
Birmingham, , United Kingdom
Northumbria Healthcare NHS Foundation Trust
North Shields, , United Kingdom
Salford Royal NHS Foundation Trust
Salford, , United Kingdom
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, , United Kingdom
Taunton and Somerset NHS Foundation Trust
Taunton, , United Kingdom
Countries
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Other Identifiers
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ROSA01
Identifier Type: -
Identifier Source: org_study_id
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