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NCT05565456
Intercorporal Bone Graft Measurement Study
Conditions: Spondylolisthesis, Spinal Fusion
Sex: All
Ages: 45 Years – 80 Years
Healthy volunteers: No
Enrollment: 30
Sponsor: Rijnstate Hospital
Location: Rijnstate Hospital Arnhem Gelderland
Summary
Instrumented lumbar fusion surgery is often accompanied by interbody fusion using an autologous bone graft that is supposed to expand and remodel to achieve a rigid and lasting bony construction between two vertebrae. However, there is a dearth of knowledge regarding the process of biological remodelling of intercorporal bone grafts. Also, a valid and reliable assessment of fusion status remains challenging because there is no objective tool available to quantify the bone remodelling process. CT-based Hounsfield Units correlate with Bone Mineral Density and can be used as a proxy to establish trajectories over time to assess changes in bone mineral density from the bone graft.
Eligibility Criteria
Inclusion criteria:
* non-responsiveness to non-operative treatment in the six months prior to study enrolment
* fusion indicated for only one segment in the L1 to S1/ilium region
* between the age of 45 and 80.
Exclusion criteria:
* receiving revision spine surgery
* not wanting to provide informed consent
* pregnant or expecting to be pregnant within in the next two years.
Source: ClinicalTrials.gov (NCT05565456). StuddyBuddy aggregates publicly available trial information.