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NOT YET RECRUITING

NCT07199075

Rate of Bone Union After Surgery With Stand-alone Fibergraft

Sponsor: AO Innovation Translation Center

View on ClinicalTrials.gov

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

Official title: Fusion Rate of Anterior Lumbar Interbody Fusion and Extreme Lateral Interbody Fusion Using Titanium Cages Filled With Stand-alone Fibergraft in Lumbar Spinal Fusion

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

Start Date

2025-10-31

Completion Date

2026-05-30

Last Updated

2025-09-30

Healthy Volunteers

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

Inclusion Criteria: * Adults ≥ 18 years old * Diagnosed with the following lumbar spine disorders: foraminal nerve root compression, isthmic spondylolisthesis, and short-segment (1-2 levels) deformity. * Undergone primary surgery of ALIF or XLIF using titanium cages filled with standalone Fibergraft and with the following criteria fulfilled (ie, the index surgery): * ALIF (up to 2 levels) as either standalone (ie, no posterior procedure) or as an anterior first procedure with posterior procedure as a second procedure. * XLIF (up to 2 levels) as an anterior first procedure with posterior procedure as a second procedure. * Consenting to have CT scans taken to allow assessment of fusion status at 12-24 months post index surgery * This criterion is applicable to patients who have not undergone revision surgery. * For patients who have undergone revision surgery due to any reason other than nonunion, which typically occurs within 1 year of the index surgery, this criterion is only applicable if it is possible to obtain the CT scan within 12-24 months of the index surgery. If no CT scan can be taken during this window, the patient does not need to undergo the CT scan; in such cases, the CT scan that has been taken as part of the standard of care before the revision surgery will be retrospectively retrieved to assess the fusion status at the time of the revision surgery. * This criterion is not applicable to patients who underwent revision surgery due to nonunion, which typically occurs 1 year after the index surgery; these patients do not need to undergo the CT scan. In such cases, the CT scan that has been taken as part of the standard of care before the revision surgery will also be retrospectively retrieved to assess and grade the fusion status at the time of the revision surgery. * Ability to provide informed consent according to the IRB/EC defined and approved procedures Exclusion Criteria: * Revision surgery * Standalone XLIF * Posterior lumbar interbody fusion * Diagnosis of fractures, malignancies, ankylosing spondylitis, or acute cauda equina syndrome * Diagnosis of Parkinson's disease * Body mass index \> 35kg/m2

Locations (1)

St Mateenskliniek

Ubbergen, Netherlands