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Rate of Bone Union After Surgery With Stand-alone Fibergraft

NCT07199075 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-09-30

No results posted yet for this study

Summary

Some people have back problems caused by degenerative conditions or instability of the spine (eg. Spondylolisthesis). These problems can lead to pain, nerve issues, or difficulties in walking. A common treatment is a type of back surgery called lumbar interbody fusion, which helps stabilize the spine.

At the St. Maartenskliniek in the Netherlands, doctors have been using a special material called Fibergraft Bioactive Glass Putty for such surgeries since 2023. This material helps bones grow and heal, and it's placed inside the spine without needing extra bone from another part of the body.

This study will look at how well this material works by evaluating how many patients' bones successfully healed after surgery using this material. It will also look at how patients feel and recover after the procedure

Conditions

  • Spine Degeneration
  • Spine Disorder
  • Spine Pain
  • Spine Fusion
  • Spine Fusion for Degenerative Spine Disease
  • Nerve Root Compress;Lumbosac
  • Spondylolisthesis

Interventions

BEHAVIORAL

Questionnaires

Questionnaires * Oswestry Disability Index (ODI) * Pain NRS lower back and (wors side) leg * EQ-5D-3L

RADIATION

Computer Tomography

One additional CT scan is performed for some patients

Sponsors & Collaborators

  • AO Innovation Translation Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2026-05-30
Completion
2026-05-30

Countries

  • Netherlands

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 NCT07199075 on ClinicalTrials.gov