Trials / Not Yet Recruiting

Not Yet RecruitingNCT07199075

Rate of Bone Union After Surgery With Stand-alone Fibergraft

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

Status: Not Yet Recruiting
Phase: —
Study type: Observational
Enrollment: 80 (estimated)

Sponsor: AO Innovation Translation Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

Interventions

Type	Name	Description
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

Timeline

Start date: 2025-10-31
Primary completion: 2026-05-30
Completion: 2026-05-30
First posted: 2025-09-30
Last updated: 2025-09-30

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT07199075. Inclusion in this directory is not an endorsement.