Clinical Study of Bone Graft Substitutes in Orthopaedic and Spinal Applications.
ROSA
A Multi-centred, Post-market Clinical Follow-up Study of Synthetic Bone Graft Substitutes for Use in Orthopaedic and Spinal Applications.
1 other identifier
observational
220
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2018
CompletedFirst Posted
Study publicly available on registry
June 27, 2018
CompletedStudy Start
First participant enrolled
June 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedApril 4, 2025
April 1, 2025
6.7 years
June 18, 2018
April 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Primary endpoints will be successful radiographic bone repair.
Bone formation and material resorption, observable by x-ray/MRI
12 months
Study Arms (7)
HA Paste in Spine
Evaluation of HA Paste in spinal fusion procedures o Spinal cage filling
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
Granulated Paste in Spine
Evaluation of Granulated Paste in spinal fusion procedures o Spinal cage filling
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
Granules in Spine
Evaluation of Granules in spinal fusion procedures o Spinal cage filling
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
Block in long bone & extremities
Evaluation of Blocks in long bone and extremity group: o High tibial osteotomies with fixation
Interventions
orthopaedic or spine bony defects
Eligibility Criteria
male or female 18-80 meeting the inclusion criteria, provided no exclusion criteria are met:
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ceramisys Ltdlead
Study Sites (7)
Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster, South Yorkshire, DN2 5LT, 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
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2018
First Posted
June 27, 2018
Study Start
June 13, 2019
Primary Completion
March 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
April 4, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share