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Intercorporal Bone Graft Measurement Study

StatusActive, Not Recruiting
PhaseNot specified
Started2022-12-02
View on ClinicalTrials.gov ↗

Amendment history

2026-06-22
Study Status v5
Primary completion date2025-11→2026-11-01
Completion date2025-11→2026-11-01
2025-08-04
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v4
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2024-04-10
Study Status v3
Re-verified, no change to tracked fields
2022-12-12
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-11→confirmed 2022-12-02
Study sitesdetails revised at 1 of 1 site
2022-10-05
Study Status, Study Description, Outcome Measures, Eligibility v1
Secondary endpoints4 entries, revised
36-item Research and Development-36 (RAND-36) Health Survey, Dutch version.
Study description-8 characters
[...] evolution of bone graft HU over time were obtained. Recently we have explored the feasibility of HU measurements after lumbar spondylodesis (Reijmer et al, submitted) was explored. The HU measurement procedure that was developed during thi [...] s of bone graft remodeling in the first year after surgery. In thisThis study, will build upon the results of the former study in an effor [...]
2022-09-29
Original filing
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.
Trial Details
NCT Number NCT05565456
Lead Sponsor Rijnstate Hospital
Conditions Spondylolisthesis, Spinal Fusion
Enrollment 30 participants
Start Date 2022-12-02
Primary Completion 2026-11-01 (estimated)
Study Completion 2026-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-25