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Fusion Rate of Anterior Lumbar Interbody Fusion and Extreme Lateral Interbody Fusion Using Titanium Cages Filled With Stand-alone Fibergraft in Lumbar Spinal Fusion
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
Lumbar interbody fusion is an established procedure for patients with lumbar degenerative conditions and spondylolisthesis, with symptoms of pain, radiculopathy, and/or myelopathy. Completion of fusion, ie, union, of an intended motion segment remains a desirable endpoint of spinal fusion, supported by the observations that pseudoarthrosis, ie, nonunion, following spinal fusion is correlated with poorer patient outcomes. Iliac crest bone autograft is considered the gold standard for spinal fusion with excellent fusion rates and clinical outcomes. However, its clinical use has been restricted due to limited availability of harvestable bone, donor-site morbidity, increased surgical time, and the need for additional surgical staff and associated costs. As a result, there has been great interest in the search for bone graft substitutes to replace or reduce the amount of autograft, which will lower the risks associated with the harvesting procedure while still providing a favorable environment for a solid fusion. A wide range of synthetic bone grafts have been explored, including ceramics, bioactive glasses, and polymer-based compounds. Although bioactive glasses have been used in spinal fusion for three decades, literature on them is dispersed over the wide array of bioactive glasses investigated and numerous small clinical studies. There is marked variability in these studies in terms of the patient population, indications, procedures performed, single- vs multi-level procedures, types of bioactive glasses, use of autografts, duration of follow-up (FU), and methods to determine fusion status. It is therefore difficult to draw conclusions on the optimal bioactive glass for a particular application. Nonetheless, the current literature suggests that bioactive glasses may be effective as bone graft extenders when combined with autograft to promote spinal fusion, yielding at least noninferior fusion rates when compared with autograft alone. There is limited data regarding the effectiveness of bone glasses as standalone bone graft substitutes or in interbody fusion procedures. This single-center study to be conducted at the St. Maartenskliniek, the Netherlands, aims to address this knowledge gap. Since 2023, the hospital has consistently used Fibergraft Bioactive Glass (BG) Putty, a product from the FIBERGRAFTTM Bioactive Bone Graft Substitute family (Johnson \& Johnson MedTech), as standalone cage fillers for anterior lumbar interbody fusion (ALIF) and extreme lateral interbody fusion (XLIF). This provides an opportunity for a case series to determine the fusion rate for bioactive glass as a standalone bone graft substitute in lumbar interbody fusion.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
St Mateenskliniek
Ubbergen, Netherlands
Start Date
October 31, 2025
Primary Completion Date
May 30, 2026
Completion Date
May 30, 2026
Last Updated
September 30, 2025
80
ESTIMATED participants
Questionnaires
BEHAVIORAL
Computer Tomography
RADIATION
Lead Sponsor
AO Innovation Translation Center
NCT06202443
NCT07026552
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05452694