Bone SubstitutesGreenBricNCT03836404
Pre-market Study to Evaluate Safety and Performance of GreenBone Implant
A study testing Iliac crest reconstruction surgery in people with Bone Substitutes, run by GreenBone Ortho S.p.A. at 1 site in United Kingdom.
Trial summary
Multi-center, prospective, open-label, single-arm, first-in-human clinical investigation. The patient enrollment will be as follow: initial 5 patients enrolled at PI site. The other remaining patients will be enrolled in the three sites only after positive evaluation of the 3 months Follow Up (FU) interim report… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bone Substitutes
- What is being tested?
- Iliac crest reconstruction surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Mar 2019to 19 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female Patients.
- Patients aged ≥ 18 and ≤ 70 years old.
- Patients requiring iliac crest reconstruction secondary to pelvic fusion.
- Patients understanding the nature of the study and providing their informed consent to participation.
- Patients willing and able to attend the visits and procedures foreseen by study protocol.
Who cannot join
- Patients with bone infections at the time of enrolment.
- Patients with bone malignant tumor(s) at the time of enrolment.
- Patients who have been treated with chemotherapy or radiotherapy within 12 months before the study enrolment.
- Patients with concomitant infectious systemic diseases at the time of enrolment.
- Patients with known inflammatory systemic diseases at the time of enrolment.
- Patients with concomitant myeloproliferative disorders at the time of enrolment.
Show all 14Show fewer
- Patients currently treated with systemic immunosuppressive agents, including steroids.
- Patients with active autoimmune disease.
- Patients with coagulopathy or bleeding disorders.
- Patients who have received a previous treatment of bone substitution in the same anatomical site.
- Patients with known or suspected allergy or hypersensitivity to the GreenBone Implant components.
- Patients who are participating or have participated in any other conflicting studies within the 30 days before the study enrolment. (This does not include patients who have taken part in other non-conflicting non-interventional or observational studies.
- These patients may still be eligible).
- Pregnant women and/or women that intend to be pregnant within 6 or 12 months from surgery.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Trauma and Orthopaedic Surgery, Leeds General Infirmary
Leeds, LS13EX
About this study
Official title: Pre-market, Multi-center, National, Open-label, Single-arm Study to Evaluate the Safety and Performance of a Class III Medical Device (GreenBone Implant) for Iliac Crest Reconstruction Following Bone Graft Harvesting for Pelvic Fusion
Multi-center, prospective, open-label, single-arm, first-in-human clinical investigation. The patient enrollment will be as follow: initial 5 patients enrolled at PI site. The other remaining patients will be enrolled in the three sites only after positive evaluation of the 3 months Follow Up (FU) interim report analysis by Data Safety Monitoring Board (DSMB). The Patients enrolled in this clinical investigation will undergo a scheduled surgery aiming to reconstruct iliac crest bone defect using GreenBone Implant. After surgery, the Patients will be monitored at pre-scheduled visits up to 6 months. The FU will be extended at 12 months only in case of no complete healing and/or in case of no resolved SAE at the 6 months FU visit. Adverse events, pain, quality of life and X-ray will be evaluated at scheduled follow-up visits. An independent DSMB will review the safety reports at regular intervals and Serious Adverse Events (SAE) as soon as reported, to protect Patients participating in the study. As specified before, an adaptive interim analysis will be performed when at least 5 Patients will have completed the 3 month follow up visit, (V5). The DSMB will review the results of the interim analysis with respect to the primary endpoint (safety) in order to continue the study up to 15 Patients.
Read the detailed description
This is a pre-market multi-centre, national, open label, single-arm, study to evaluate the safety and performance of a Class III medical device (GreenBone Implant) for iliac crest reconstruction following bone graft harvesting for pelvic fusion. During pelvic fusion a considerable part of the iliac crest is removed and it is used as autologous bone graft for the fusion of the pubis symphysis. The bone defect that is formed in the iliac crest is usually filled with bone obtained from the cows (bovine xenograft) and or human donors (allograft). This carries the risk of transferring disease from animals and/or humans to the patient; there is also a risk of host local allergic reaction. Bone substitutes are devoid of the above risks and therefore they could be used alternatively to xenografts and allografts.
GreenBone is a ceramic resorbable bone scaffold that has very similar structure to bone. It can be produced in large quantities, shaped easily and sterilised without losing its properties. Consequently, it is an ideal substitute that could be used to fill bone defects. This study will assess the safety of using GreenBone to reconstruct iliac crest defects. Moreover it will assess its capacity of promoting new bone formation. The investigators will recruit 15 patients who will undergo pelvic fusion and instead of bovine xenograft the investigators will use the GreenBone implant for the iliac crest reconstruction.
Patients will be followed up for 6 months in total. Safety will be evaluated by monitoring local and potential systemic reactions; its bone forming capacity will also be assessed by its integration into the iliac crest.
- Conditions
- Bone Substitutes
- Being tested
- Iliac crest reconstruction surgery
- Keywords
- Bone substitute, Bone regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iliac crest reconstruction surgeryDevice
When autologous bone graft is needed for the treatment of non-unions or bone defects, is harvested from the pelvic iliac crest. Harvested tricortical graft blocks are used to facilitate fusion of joints (ie pubis symphysis, sacroiliac joint), to structurally support metaphyseal areas of articular impaction injuries and to fill in metaphyseal bone voids. The GreenBone device, with its inherent physical and biomimic properties, possesses similar structural properties to bone, thus, being the ideal material to be used for the treatment of the bone defect (3- 4cm) induced from the harvested tricortical iliac crest, restoring therefore the pelvic anatomy and minimising the risk of chronic pain, haematoma formation and herniation of the abdominal contents.
| Study group | Role | What they receive |
|---|---|---|
| Iliac Crest reconstruction surgery | Experimental | The patients in the study group will be surgically treated and the GreenBone bone substitute will be implanted Receives: Device: Iliac crest reconstruction surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation assessed by Evaluation of adverse events rate
Evaluation of adverse events rate during the study period. All adverse occurrences (serious/non-serious or device related/non-device related) will be recorded prospectively, categorized and evaluated for causality using defined criteria.
Measured: Overall study period up to 6 months
Secondary outcomes (6)
Device Implant Technical Success
Technical Success, defined as successful delivery of the bone substitute in the target defect bone evaluated at V2 (at surgical procedure);
Measured: At the end of surgical procedure (visit 2, 1 day)
Bone regeneration evaluation
Evaluation of the bone regeneration in the area of intervention, by means of X-ray and/or CT examination by a radiologist, on visit V3, V4, V5, V6, V7; X-ray scoring systems have been implemented according to the criteria proposed by Lane and Sandhu (bone formation, union and remodeling) (Lane 1987)
Measured: At the end of visits 3, 4, 5, 6, 7 (respectively performed 1, 2, 3, 6, 12 months after the surgery, each visit is 1 day)
Quality of Life evaluation
Evaluation of Quality of Life by means of a validated EuroQol questionnaire administered at every visit from V1 to V6/V7 (excluding visit 2) (Price 1983)
Measured: At screening visit (V1) and at the end of visits 3, 4, 5, 6, 7 (respectively performed 1, 2, 3, 6, 12 months after the surgery, each visit is 1 day)
Evaluation of Pain
Evaluation of degree of pain perceived by the Patient, by means of a Visual Analogue Score (VAS) that a scale with 10 points, from 0 to 10. 0 indicates "no pain at all" and 10 the "worst pain ever"
Measured: between 1 and 6 months
Treatment tolerability
Evaluation of global tolerability to treatment of Patient (by the Investigator), through a standardized EuroQol questionnaire, on every visit from V3 to V6/V7
Measured: At the end of visits 3, 4, 5, 6, 7 (respectively performed 1, 2, 3, 6, 12 months after the surgery, each visit is 1 day)
Reinterventions number
Evaluation of the number of re-interventions occurring for the Patient throughout the . 6 months observation period.
Measured: between 1 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start6 Mar 2019
- Primary completion29 Apr 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone SubstitutesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- GreenBone Ortho S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Giannoudis, MD, Principal investigator, Leeds Teaching Hospital NHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836404
- Sponsor's protocol ID
- GB-01-18
- Acronym
- GreenBric
- Status last verified
- Jun 2024
- First submitted
- 7 Feb 2019
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Giannoudis PV, Andrzejwski P, Chloros G, Hensor EMA. Safety and performance of a novel synthetic biomimetic scaffold for iliac crest defect reconstruction during surgical treatment of pelvic girdle pain: a first-in-human trial. Br Med Bull. 2025 Jan 16;153(1):ldae023. doi: 10.1093/bmb/ldae023.
PubMed 39821211
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
- Pre-market, Multi-center, National, Open-label, Single-arm Study to Evaluate the Safety and Performance of a Class III Medical Device (GreenBone Implant) for Iliac Crest Reconstruction Following Bone Graft Harvesting for Pelvic Fusion
- ClinicalTrials.gov ID
- NCT03836404
- Acronym / sponsor ID
- GreenBric / GB-01-18
- Conditions
- Bone Substitutes
- Keywords
- Bone substitute, Bone regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- GreenBone Ortho S.p.A.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 11 Feb 2019 (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.
Multi-center, prospective, open-label, single-arm, first-in-human clinical investigation. The patient enrollment will be as follow: initial 5 patients enrolled at PI site. The other remaining patients will be enrolled in the three sites only after positive evaluation of the 3 months Follow Up (FU) interim report analysis by Data Safety Monitoring Board (DSMB). The Patients enrolled in this clinical investigation will undergo a scheduled surgery aiming to reconstruct iliac crest bone defect using GreenBone Implant. After surgery, the Patients will be monitored at pre-scheduled visits up to 6 months. The FU will be extended at 12 months only in case of no complete healing and/or in case of no resolved SAE at the 6 months FU visit. Adverse events, pain, quality of life and X-ray will be evaluated at scheduled follow-up visits. An independent DSMB will review the safety reports at regular intervals and Serious Adverse Events (SAE) as soon as reported, to protect Patients participating in the study. As specified before, an adaptive interim analysis will be performed when at least 5 Patients will have completed the 3 month follow up visit, (V5). The DSMB will review the results of the interim analysis with respect to the primary endpoint (safety) in order to continue the study up to 15 Patients.
Detailed description
This is a pre-market multi-centre, national, open label, single-arm, study to evaluate the safety and performance of a Class III medical device (GreenBone Implant) for iliac crest reconstruction following bone graft harvesting for pelvic fusion. During pelvic fusion a considerable part of the iliac crest is removed and it is used as autologous bone graft for the fusion of the pubis symphysis. The bone defect that is formed in the iliac crest is usually filled with bone obtained from the cows (bovine xenograft) and or human donors (allograft). This carries the risk of transferring disease from animals and/or humans to the patient; there is also a risk of host local allergic reaction. Bone substitutes are devoid of the above risks and therefore they could be used alternatively to xenografts and allografts.
GreenBone is a ceramic resorbable bone scaffold that has very similar structure to bone. It can be produced in large quantities, shaped easily and sterilised without losing its properties. Consequently, it is an ideal substitute that could be used to fill bone defects. This study will assess the safety of using GreenBone to reconstruct iliac crest defects. Moreover it will assess its capacity of promoting new bone formation. The investigators will recruit 15 patients who will undergo pelvic fusion and instead of bovine xenograft the investigators will use the GreenBone implant for the iliac crest reconstruction.
Patients will be followed up for 6 months in total. Safety will be evaluated by monitoring local and potential systemic reactions; its bone forming capacity will also be assessed by its integration into the iliac crest.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iliac Crest reconstruction surgery | Experimental | Device: Iliac crest reconstruction surgeryThe patients in the study group will be surgically treated and the GreenBone bone substitute will be implanted |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female Patients.
- Patients aged ≥ 18 and ≤ 70 years old.
- Patients requiring iliac crest reconstruction secondary to pelvic fusion.
- Patients understanding the nature of the study and providing their informed consent to participation.
- Patients willing and able to attend the visits and procedures foreseen by study protocol.
Key exclusion criteria (14 listed)
- Patients with bone infections at the time of enrolment.
- Patients with bone malignant tumor(s) at the time of enrolment.
- Patients who have been treated with chemotherapy or radiotherapy within 12 months before the study enrolment.
- Patients with concomitant infectious systemic diseases at the time of enrolment.
- Patients with known inflammatory systemic diseases at the time of enrolment.
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 |
|---|---|---|
| Iliac crest reconstruction surgeryWhen autologous bone graft is needed for the treatment of non-unions or bone defects, is harvested from the pelvic iliac crest. Harvested tricortical graft blocks are used to facilitate fusion of joints (ie pubis symphysis, sacroiliac joint), to structurally support metaphyseal areas of articular impaction injuries and to fill in metaphyseal bone voids. The GreenBone device, with its inherent physical and biomimic properties, possesses similar structural properties to bone, thus, being the ideal material to be used for the treatment of the bone defect (3- 4cm) induced from the harvested tricortical iliac crest, restoring therefore the pelvic anatomy and minimising the risk of chronic pain, haematoma formation and herniation of the abdominal contents. | Device | Iliac Crest reconstruction surgery |
Primary outcome
Safety Evaluation assessed by Evaluation of adverse events rate
Time frame: Overall study period up to 6 months
Evaluation of adverse events rate during the study period. All adverse occurrences (serious/non-serious or device related/non-device related) will be recorded prospectively, categorized and evaluated for causality using defined criteria.
6 secondary outcomes
Device Implant Technical Success
Time frame: At the end of surgical procedure (visit 2, 1 day)
Bone regeneration evaluation
Time frame: At the end of visits 3, 4, 5, 6, 7 (respectively performed 1, 2, 3, 6, 12 months after the surgery, each visit is 1 day)
Quality of Life evaluation
Time frame: At screening visit (V1) and at the end of visits 3, 4, 5, 6, 7 (respectively performed 1, 2, 3, 6, 12 months after the surgery, each visit is 1 day)
Evaluation of Pain
Time frame: between 1 and 6 months
Treatment tolerability
Time frame: At the end of visits 3, 4, 5, 6, 7 (respectively performed 1, 2, 3, 6, 12 months after the surgery, each visit is 1 day)
Reinterventions number
Time frame: between 1 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Derived from this study: PubMed 39821211Giannoudis PV, Andrzejwski P, Chloros G, Hensor EMA. Safety and performance of a novel synthetic biomimetic scaffold for iliac crest defect reconstruction during surgical treatment of pelvic girdle pain: a first-in-human trial. Br Med Bull. 2025 Jan 16;153(1):ldae023. doi: 10.1093/bmb/ldae023.
- Individual participant dataSharing planned: Undecided
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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.
Peter Giannoudis, MD principal investigator
Leeds Teaching Hospital NHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iliac crest reconstruction surgery in people with Bone Substitutes, run by GreenBone Ortho S.p.A. at 1 site 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 5 inclusion and 14 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: finished, 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 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety Evaluation assessed by Evaluation of adverse events rate (time frame: Overall study period up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03836404, which also lists 1 linked publication.
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.