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Active Not Recruiting 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05565456). StuddyBuddy aggregates publicly available trial information.