Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic InjuryOSsIRISNCT06156904
OSsIRIS Study - A Post-market Clinical Follow-up Investigation.
An observational study of Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury, run by GreenBone Ortho S.p.A. at 4 sites in 2 countries.
Trial summary
This is a prospective, observational, non-randomized, multicenter, international post-market clinical follow-up investigation aiming to confirm the performance and safety of the bone substitute b.Bone after implantation in patients in isolation or as a graft expander requiring bone grafting for the treatment of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury
- What is being tested?
- Bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities.
- Type of treatment
- Medical device
- How many people
- 135 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 31 Jan 2024to Oct 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients both sexes requiring bone grafting with the synthetic bone substitute b.Bone, according to the standard clinical practice.
Who may be able to join
- Patient is undergoing a standard of care bone grafting with b.Bone for the treatment of surgically created bone defects or bone defects resulting from traumatic injury in the extremities and pelvis according to the approved IFU.
- Male or female patient ≥ 18 years old.
- Patients willing and able to attend the standard of care follow-up visits and procedures.
- Patients who have provided consent to participate in the clinical investigation and to the processing of personal data.
Who cannot join
- Patients with any conditions in which b.Bone is not indicated according to the contraindications defined in the IFU of b.Bone
- Patients who are currently enrolled in another clinical investigation/study that would directly interfere with the current clinical investigation, except when the patient is participating in a purely observational study with no associated treatments.
- Woman who is pregnant or breast-feeding.
- Patients who, in the opinion of the Investigator, have an existing condition that could affect their ability to complete patient reported questionnaires or be compliant with the standard of care follow-up visits and examinations for the duration of the clinical investigation.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Germany2 sites, 2 recruiting
- Recruiting
BG Klinikum Unfallkrankenhaus Berlin
Berlin, 12683
Nikolai Spranger, Dr, nikolai.spranger@ukb.de
Nikolai Spranger, Dr
- Recruiting
Trauma Surgery Department - University Hospital Regensburg
Regensburg, 93053
Volker Alt, Dr, volker.alt@ukr.de
Volker Alt, Dr
United Kingdom2 sites, 2 recruiting
- Recruiting
Hull University Teaching Hospitals NHS Trust
Hull, HU3 2JZ
Hermant Sharma, Dr, hemant.sharma5@nhs.net
Hermant Sharma, Dr
- Recruiting
Department of Trauma and Orthopaedic Surgery, Leeds General Infirmary
Leeds, LS13EX
Peter Giannoudis, Dr, peter.giannoudis@nhs.net
Peter Giannoudis, Dr
About this study
Official title: A Post-market Clinical Follow-up Investigation to Confirm the Performance and Safety of the Bone Substitute b.Bone in Extremities and Pelvis.
This is a prospective, observational, non-randomized, multicenter, international post-market clinical follow-up investigation aiming to confirm the performance and safety of the bone substitute b.Bone after implantation in patients in isolation or as a graft expander requiring bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities. Patients enrolled in this clinical investigation will undergo orthopaedic surgery with b.Bone as recommended by the specialist and according to orthopaedic standard procedures. Patients will be evaluated preoperatively and at different time points after the surgery according to the standard practice of the sites. The expected schedule is at month 3, month 6 and month 12. Patients who require longer follow-up and could be subjected to metalwork removal will be evaluated up to 24 months. All safety data will be collected from patient inclusion to the end of the clinical investigation.
All study visits will coincide with any of the patient's routine clinical visits, without interfering with the investigator's clinical duties.
It is planned to enroll 135-193 patients from approximately 15 EU and UK sites.
- Being tested
- Bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities.Device
All patients enrolled in this clinical investigation will undergo a reconstruction of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone as per the standard of care at the investigational sites. Patients will be treated with b.Bone which will be used as a bone substitute in isolation or as a graft expander to promote healing in the pelvis, upper and lower extremities.
b.Bone is a bone substitute without initial mechanical properties, therefore it is to be used in conjunction with internal/external fixation devices suitable for primary stabilization.
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of b.Bone by determining the radiographic healing/union after surgery.
Number and rate of patients with successful bone healing/union observable by X-ray or CT scan.
Radiologic images will be evaluated by the surgeon according to the modified radiographic Union Scale for Tibial fractures (mRUST) classification or the modified Neer classification when applicable.
Measured: 12 months
Secondary outcomes (4)
Clinical outcomes measured by patient-reported outcomes - Pain
Change in the patient-reported pain using the Visual Analoge Scale from baseline to month 3, month 6 and month 12 post-treatment.
Patient-completed questionnaire scoring pain by using 10 cm line. Zero (0) indicates no pain at all and ten (10) the worst pain ever.
Measured: Baseline and 3, 6 and 12 months
Clinical outcomes measured by patient-reported outcomes - Quality of Life
Change in the patient-reported Quality of Life assessed by Health Questionnaire from baseline to month 3, month 6 and month 12 post-treatment.
Measured: Baseline and 3, 6 and 12 months
Evaluate the safety of b.Bone during the clinical investigation period - AE and SAE
Number and rate of procedure and device-related adverse events (AEs) and Serious adverse events (SAEs) during the clinical investigation period.
Measured: Up to 24 months
Evaluate the safety of b.Bone during the clinical investigation period - rate of reinterventions
Rate of reinterventions related to the treatment applied during the clinical investigation
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start31 Jan 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic InjuryStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GreenBone Ortho S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Volker Alt, Dr, Principal investigator, Director of the Trauma Surgery Department University Hospital Regensburg, GermanyPeter Giannoudis, Dr, Principal investigator, Honorary Consultant Trauma & Orthopaedic Surgery, Leeds General Infirmary, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156904
- Sponsor's protocol ID
- CIP-GB002-22-0123
- Acronym
- OSsIRIS
- Status last verified
- Jun 2024
- First submitted
- 27 Nov 2023
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Clinical Follow-up Investigation to Confirm the Performance and Safety of the Bone Substitute b.Bone in Extremities and Pelvis.
- ClinicalTrials.gov ID
- NCT06156904
- Acronym / sponsor ID
- OSsIRIS / CIP-GB002-22-0123
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- GreenBone Ortho S.p.A.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 5 Dec 2023 (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 a prospective, observational, non-randomized, multicenter, international post-market clinical follow-up investigation aiming to confirm the performance and safety of the bone substitute b.Bone after implantation in patients in isolation or as a graft expander requiring bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities. Patients enrolled in this clinical investigation will undergo orthopaedic surgery with b.Bone as recommended by the specialist and according to orthopaedic standard procedures. Patients will be evaluated preoperatively and at different time points after the surgery according to the standard practice of the sites. The expected schedule is at month 3, month 6 and month 12. Patients who require longer follow-up and could be subjected to metalwork removal will be evaluated up to 24 months. All safety data will be collected from patient inclusion to the end of the clinical investigation.
All study visits will coincide with any of the patient's routine clinical visits, without interfering with the investigator's clinical duties.
It is planned to enroll 135-193 patients from approximately 15 EU and UK sites.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients both sexes requiring bone grafting with the synthetic bone substitute b.Bone, according to the standard clinical practice.
Key inclusion criteria (4 listed)
- Patient is undergoing a standard of care bone grafting with b.Bone for the treatment of surgically created bone defects or bone defects resulting from traumatic injury in the extremities and pelvis according to the approved IFU.
- Male or female patient ≥ 18 years old.
- Patients willing and able to attend the standard of care follow-up visits and procedures.
- Patients who have provided consent to participate in the clinical investigation and to the processing of personal data.
Key exclusion criteria (4 listed)
- Patients with any conditions in which b.Bone is not indicated according to the contraindications defined in the IFU of b.Bone
- Patients who are currently enrolled in another clinical investigation/study that would directly interfere with the current clinical investigation, except when the patient is participating in a purely observational study with no associated treatments.
- Woman who is pregnant or breast-feeding.
- Patients who, in the opinion of the Investigator, have an existing condition that could affect their ability to complete patient reported questionnaires or be compliant with the standard of care follow-up visits and examinations for the duration of the clinical investigation.
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 grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities.All patients enrolled in this clinical investigation will undergo a reconstruction of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone as per the standard of care at the investigational sites. Patients will be treated with b.Bone which will be used as a bone substitute in isolation or as a graft expander to promote healing in the pelvis, upper and lower extremities. b.Bone is a bone substitute without initial mechanical properties, therefore it is to be used in conjunction with internal/external fixation devices suitable for primary stabilization. | Device | – |
Primary outcome
Performance of b.Bone by determining the radiographic healing/union after surgery.
Time frame: 12 months
Number and rate of patients with successful bone healing/union observable by X-ray or CT scan. Radiologic images will be evaluated by the surgeon according to the modified radiographic Union Scale for Tibial fractures (mRUST) classification or the modified Neer classification when applicable.
4 secondary outcomes
Clinical outcomes measured by patient-reported outcomes - Pain
Time frame: Baseline and 3, 6 and 12 months
Clinical outcomes measured by patient-reported outcomes - Quality of Life
Time frame: Baseline and 3, 6 and 12 months
Evaluate the safety of b.Bone during the clinical investigation period - AE and SAE
Time frame: Up to 24 months
Evaluate the safety of b.Bone during the clinical investigation period - rate of reinterventions
Time frame: Up to 24 months
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 7 Jun 2024.
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.
Volker Alt, Dr principal investigator
Director of the Trauma Surgery Department University Hospital Regensburg, Germany
Peter Giannoudis, Dr principal investigator
Honorary Consultant Trauma & Orthopaedic Surgery, Leeds General Infirmary, United Kingdom
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury, run by GreenBone Ortho S.p.A. at 4 sites in 2 countries.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, 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?
Contact Sonia Granados, MSc (+393450954463, sonia.granados@greenbone.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of b.Bone by determining the radiographic healing/union after surgery. (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 7 Jun 2024.