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OpenTrials
Completed

NCT Number: NCT05906394

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

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.

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Key information

Conditions

Degenerative Spinal Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Magdeburg, Magdeburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Successful fusion rate by CT scan assessments after surgery.

    Time frame: 12 months

Secondary outcomes

  1. Successful fusion rate by CT scan assessments after surgery.

    Time frame: 6 months

  2. Back and Leg pain assessed by Visual Analog Scale.

    Time frame: Baseline, 6 weeks, 3, 6, and 12 months post-treatment.

  3. Functional activity assessed by Oswestry Disability Index.

    Time frame: Baseline, 6 weeks, 3, 6, and 12 months post-treatment.

  4. Quality of life assessed by Health Questionnaire

    Time frame: Baseline, 6 weeks, 3, 6, and 12 months post-treatment.

  5. Neurological function

    Time frame: Baseline, 3, 6, and 12 months post-treatment.

    Maintenance/improvement of neurological function postoperatively versus baseline.

  6. Rate of Adverse Events through the clinical trial period.

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

GreenBone Ortho S.p.A.

Industry

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2023
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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