Bone DeformityROSANCT03570606
Clinical Study of Bone Graft Substitutes in Orthopaedic and Spinal Applications.
An observational study of Bone Deformity, run by Ceramisys Ltd at 7 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bone Deformity
- What is being tested?
- bone graft substitute
- Type of treatment
- Medical device
- How many people
- 220 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 13 Jun 2019to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: male or female 18-80 meeting the inclusion criteria, provided no exclusion criteria are met:
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Sandwell and West Birmingham NHS Trust of City Hospital
Birmingham
The Royal Orthopaedic Hospital NHS Foundation Trust
Birmingham
Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster, South Yorkshire, DN2 5LT
Northumbria Healthcare NHS Foundation Trust
North Shields
Salford Royal NHS Foundation Trust
Salford
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent
Taunton and Somerset NHS Foundation Trust
Taunton
About this study
Official title: A Multi-centred, Post-market Clinical Follow-up Study of Synthetic Bone Graft Substitutes for Use in Orthopaedic and Spinal Applications.
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.
- Conditions
- Bone Deformity
- Being tested
- bone graft substitute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone graft substituteDevice
orthopaedic or spine bony defects
| Study group | Role | What they receive |
|---|---|---|
| HA Paste in Spine | Evaluation of HA Paste in spinal fusion procedures
o Spinal cage filling Receives: Device: bone graft substitute | |
| 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 Receives: Device: bone graft substitute | |
| Granulated Paste in Spine | Evaluation of Granulated Paste in spinal fusion procedures
o Spinal cage filling Receives: Device: bone graft substitute | |
| 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 Receives: Device: bone graft substitute | |
| Granules in Spine | Evaluation of Granules in spinal fusion procedures
o Spinal cage filling Receives: Device: bone graft substitute | |
| 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 Receives: Device: bone graft substitute | |
| Block in long bone & extremities | Evaluation of Blocks in long bone and extremity group:
o High tibial osteotomies with fixation Receives: Device: bone graft substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoints will be successful radiographic bone repair.
Bone formation and material resorption, observable by x-ray/MRI
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start13 Jun 2019
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ceramisys Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570606
- Sponsor's protocol ID
- ROSA01
- Acronym
- ROSA
- Status last verified
- Oct 2026
- First submitted
- 18 Jun 2018
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centred, Post-market Clinical Follow-up Study of Synthetic Bone Graft Substitutes for Use in Orthopaedic and Spinal Applications.
- ClinicalTrials.gov ID
- NCT03570606
- Acronym / sponsor ID
- ROSA / ROSA01
- Conditions
- Bone Deformity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Ceramisys LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| HA Paste in Spine | – | Device: bone graft substituteEvaluation of HA Paste in spinal fusion procedures o Spinal cage filling |
| HA Paste in long bone & extremities | – | Device: bone graft substituteEvaluation 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 | – | Device: bone graft substituteEvaluation of Granulated Paste in spinal fusion procedures o Spinal cage filling |
| Granulated Paste in long bone & extremities | – | Device: bone graft substituteEvaluation 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 | – | Device: bone graft substituteEvaluation of Granules in spinal fusion procedures o Spinal cage filling |
| Granules in long bone & extremities | – | Device: bone graft substituteEvaluation 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 | – | Device: bone graft substituteEvaluation of Blocks in long bone and extremity group: o High tibial osteotomies with fixation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- male or female 18-80 meeting the inclusion criteria, provided no exclusion criteria are met:
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bone graft substituteorthopaedic or spine bony defects | Device | Block in long bone & extremities, Granulated Paste in Spine, Granulated Paste in long bone & extremities, Granules in Spine, Granules in long bone & extremities, HA Paste in Spine, HA Paste in long bone & extremities |
Primary outcome
Primary endpoints will be successful radiographic bone repair.
Time frame: 12 months
Bone formation and material resorption, observable by x-ray/MRI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Bone Deformity
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Deformity, run by Ceramisys Ltd at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoints will be successful radiographic bone repair. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.