Prospective Hounsfield Unit Measurements of Intercorporal Bone Grafts Remodelling Towards Spinal Fusion

Status: Active_not_recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Rijnstate Hospital
Arnhem
Time Frame
Start Date: 2022-12-02
Completion Date: 2025-11
Participants
Target number of participants: 30
Related Therapeutic Areas
Sponsors
Leads: Rijnstate Hospital

This content was sourced from clinicaltrials.gov