A Pre-market Study to Evaluate b.Bone for Posterolateral... | NCT05906394

Studies
A Pre-market Study to Evaluate b.Bone for Posterolateral Fusion (b.Spine Clinical Trial).

NCT05906394

Sponsor

GreenBone Ortho S.p.A.

Status

Completed

Last Update Posted

Apr 20, 2025Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Degenerative Spinal Conditions

Interventions

Posterolateral Fusion

Countries

Germany
Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CIV-23-03-042713	Other Identifier	EUDAMED Number

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2023Actual

Primary Completion Date

Feb 18, 2025Actual

Completion Date

Feb 18, 2025Actual

First Submitted Date

Jun 6, 2023

First Submission Date that Met QC Criteria

Jun 14, 2023

First Posted Date

Jun 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2025

Last Update Posted Date

Apr 20, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Posterolateral Fusion	Experimental	Patients recruited for clinical investigation will undergo up to a three-level posterolateral fusion (PLF) procedure with b.Bone granules.	Procedure: Posterolateral Fusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Posterolateral Fusion	Procedure	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.

Measure	Description	Time Frame
Successful fusion rate by CT scan assessments after surgery.		12 months

Measure	Description	Time Frame
Successful fusion rate by CT scan assessments after surgery.		6 months
Back and Leg pain assessed by Visual Analog Scale.		Baseline, 6 weeks, 3, 6, and 12 months post-treatment.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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,
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Magdeburg		Magdeburg			Germany
IRCCS Istituto Ortopedico Rizzoli

Type	Date	Date Unknown
Release	Sep 22, 2025
Reset	Oct 9, 2025
Release	Jan 14, 2026
Reset	Jan 29, 2026

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 22, 2025			Oct 9, 2025
Jan 14, 2026