Degenerative Spinal ConditionsNCT05906394
A Pre-market Study to Evaluate b.Bone for Posterolateral Fusion (b.Spine Clinical Trial).
A study testing Posterolateral Fusion in people with Degenerative Spinal Conditions, run by GreenBone Ortho S.p.A. at 2 sites in 2 countries.
Trial summary
Prospective, open-label, single-arm clinical investigation. The purpose of this clinical investigation is to evaluate the bone substitute b.Bone in posterolateral fusion treatment of degenerative thoracolumbar, lumbar or lumbosacral spinal conditions, in terms of performance and safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Spinal Conditions
- What is being tested?
- Posterolateral Fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Aug 2023to 18 Feb 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient ≥ 18 years old.
- Patients requiring posterolateral fusion treatment for degenerative thoracolumbar, lumbar, or lumbosacral spinal conditions up to 8 levels.
- Patients willing and able to attend the follow-up visits and procedures foreseen by the study protocol.
- Patients who have provided written informed consent to participate in the study and the processing of personal data before any study procedure is performed.
Who cannot join
- Any previous surgical attempt(s) for spinal fusion (revision surgery) of the intended segment(s).
- Patients who have been treated with chemotherapy or radiotherapy within 12 months before the enrolment.
- Indication for spinal fusion because of an acute traumatic reason, like a spinal fracture.
- Bone infection.
- Bone malignant tumor(s).
- Concomitant infectious systemic diseases,
Show all 18Show fewer
- Inflammatory systemic diseases,
- Concomitant myeloproliferative disorders,
- Active autoimmune disease,
- Known or suspected allergy or hypersensitivity to the b.Bone device components,
- Calcium metabolism disorder (i.e. hypercalcemia),
- Known hyperthyroidism or autonomous thyroid adenoma.
- Patients currently treated with systemic immunosuppressive agents.
- Patients who are currently enrolled in another clinical study that would directly interfere with the current study, except when the patient is participating in a purely observational registry with no associated treatments.
- Body mass index (BMI) larger than 36 (morbidly obese).
- Known severe osteoporosis.
- Patients requiring instrumented fusion in the cervical spine.
- Woman who is pregnant or breast-feeding.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Pre-market, Open-label, Single-arm Study to Evaluate b.Bone for Posterolateral Fusion Treatment of Degenerative Thoracolumbar, Lumbar or Lumbosacral Spinal Disease.
Prospective, open-label, single-arm clinical investigation. The purpose of this clinical investigation is to evaluate the bone substitute b.Bone in posterolateral fusion treatment of degenerative thoracolumbar, lumbar or lumbosacral spinal conditions, in terms of performance and safety.
Subjects who meet the study selection will undergo up to a three-level posterolateral fusion using b.Bone in combination with autologous bone in a 1:1 ratio. Subjects will be followed up at discharge, week 6, Month 3, Month 6, and Month 12.
- Conditions
- Degenerative Spinal Conditions
- Being tested
- Posterolateral Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterolateral FusionProcedure or surgery
Posterolateral spinal fusion is a neurosurgical or orthopaedic surgical technique that joins two or more vertebrae. This procedure can be performed at any level in the spine (cervical, thoracic, lumbar, or sacral) and prevents any movement between the fused vertebrae.
| Study group | Role | What they receive |
|---|---|---|
| Posterolateral Fusion | Experimental | Patients recruited for clinical investigation will undergo up to a three-level posterolateral fusion (PLF) procedure with b.Bone granules. Receives: Procedure: Posterolateral Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful fusion rate by CT scan assessments after surgery.
Measured: 12 months
Secondary outcomes (6)
Successful fusion rate by CT scan assessments after surgery.
Measured: 6 months
Back and Leg pain assessed by Visual Analog Scale.
Measured: Baseline, 6 weeks, 3, 6, and 12 months post-treatment.
Functional activity assessed by Oswestry Disability Index.
Measured: Baseline, 6 weeks, 3, 6, and 12 months post-treatment.
Quality of life assessed by Health Questionnaire
Measured: Baseline, 6 weeks, 3, 6, and 12 months post-treatment.
Neurological function
Maintenance/improvement of neurological function postoperatively versus baseline.
Measured: Baseline, 3, 6, and 12 months post-treatment.
Rate of Adverse Events through the clinical trial period.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Aug 2023
- Primary completion18 Feb 2025
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Spinal ConditionsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- GreenBone Ortho S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giovanni Barbanti Bròdano, Dr, Principal investigator, IRCCS Istituto Ortopedico Rizzoli, Bologna - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906394
- Sponsor's protocol ID
- CIP-P010-0122
- Other IDs
- CIV-23-03-042713
- Status last verified
- Apr 2025
- First submitted
- 6 Jun 2023
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-market, Open-label, Single-arm Study to Evaluate b.Bone for Posterolateral Fusion Treatment of Degenerative Thoracolumbar, Lumbar or Lumbosacral Spinal Disease.
- ClinicalTrials.gov ID
- NCT05906394
- Acronym / sponsor ID
- CIP-P010-0122
- Conditions
- Degenerative Spinal Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- GreenBone Ortho S.p.A.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 15 Jun 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.
Prospective, open-label, single-arm clinical investigation. The purpose of this clinical investigation is to evaluate the bone substitute b.Bone in posterolateral fusion treatment of degenerative thoracolumbar, lumbar or lumbosacral spinal conditions, in terms of performance and safety.
Subjects who meet the study selection will undergo up to a three-level posterolateral fusion using b.Bone in combination with autologous bone in a 1:1 ratio. Subjects will be followed up at discharge, week 6, Month 3, Month 6, and Month 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Posterolateral Fusion | Experimental | Procedure: Posterolateral FusionPatients recruited for clinical investigation will undergo up to a three-level posterolateral fusion (PLF) procedure with b.Bone granules. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patient ≥ 18 years old.
- Patients requiring posterolateral fusion treatment for degenerative thoracolumbar, lumbar, or lumbosacral spinal conditions up to 8 levels.
- Patients willing and able to attend the follow-up visits and procedures foreseen by the study protocol.
- Patients who have provided written informed consent to participate in the study and the processing of personal data before any study procedure is performed.
Key exclusion criteria (18 listed)
- Any previous surgical attempt(s) for spinal fusion (revision surgery) of the intended segment(s).
- Patients who have been treated with chemotherapy or radiotherapy within 12 months before the enrolment.
- Indication for spinal fusion because of an acute traumatic reason, like a spinal fracture.
- Bone infection.
- Bone malignant tumor(s).
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 |
|---|---|---|
| Posterolateral FusionPosterolateral spinal fusion is a neurosurgical or orthopaedic surgical technique that joins two or more vertebrae. This procedure can be performed at any level in the spine (cervical, thoracic, lumbar, or sacral) and prevents any movement between the fused vertebrae. | Procedure or surgery | Posterolateral Fusion |
Primary outcome
Successful fusion rate by CT scan assessments after surgery.
Time frame: 12 months
6 secondary outcomes
Successful fusion rate by CT scan assessments after surgery.
Time frame: 6 months
Back and Leg pain assessed by Visual Analog Scale.
Time frame: Baseline, 6 weeks, 3, 6, and 12 months post-treatment.
Functional activity assessed by Oswestry Disability Index.
Time frame: Baseline, 6 weeks, 3, 6, and 12 months post-treatment.
Quality of life assessed by Health Questionnaire
Time frame: Baseline, 6 weeks, 3, 6, and 12 months post-treatment.
Neurological function
Time frame: Baseline, 3, 6, and 12 months post-treatment.
Rate of Adverse Events through the clinical trial period.
Time frame: Up to 12 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 20 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Giovanni Barbanti Bròdano, Dr principal investigator
IRCCS Istituto Ortopedico Rizzoli, Bologna - Italy
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterolateral Fusion in people with Degenerative Spinal Conditions, run by GreenBone Ortho S.p.A. at 2 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 18 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 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Italy. 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?
Successful fusion rate by CT scan assessments 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 20 Apr 2025.