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

NCT05906394 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-04-20

No results posted yet for this study

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.

Conditions

  • Degenerative Spinal Conditions

Interventions

PROCEDURE

Posterolateral Fusion

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.

Sponsors & Collaborators

  • GreenBone Ortho S.p.A.

    lead INDUSTRY

Principal Investigators

  • Giovanni Barbanti Bròdano, Dr · IRCCS Istituto Ortopedico Rizzoli, Bologna - Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-02-18
Completion
2025-02-18

Countries

  • Germany
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05906394 on ClinicalTrials.gov