Clinical Study of Bone Graft Substitutes in Orthopaedic and Spinal Applications.
- Conditions
- Bone Deformity
- Interventions
- Device: bone graft substitute
- Registration Number
- NCT03570606
- Lead Sponsor
- Ceramisys Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 220
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;
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Granules in long bone & extremities bone graft substitute 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 Granules in Spine bone graft substitute Evaluation of Granules in spinal fusion procedures o Spinal cage filling HA Paste in Spine bone graft substitute Evaluation of HA Paste in spinal fusion procedures o Spinal cage filling Granulated Paste in long bone & extremities bone graft substitute 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 HA Paste in long bone & extremities bone graft substitute 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 Block in long bone & extremities bone graft substitute Evaluation of Blocks in long bone and extremity group: o High tibial osteotomies with fixation Granulated Paste in Spine bone graft substitute Evaluation of Granulated Paste in spinal fusion procedures o Spinal cage filling
- Primary Outcome Measures
Name Time Method Primary endpoints will be successful radiographic bone repair. 12 months Bone formation and material resorption, observable by x-ray/MRI
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
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