Measuring Bone Graft Changes in Spinal Surgery
Prospective Hounsfield Unit Measurements of Intercorporal Bone Grafts Remodelling Towards Spinal Fusion
Rijnstate Hospital · NCT05565456
This study looks at how bone grafts used in lower back surgery change over time to see if they help the spine heal properly.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | Rijnstate Hospital (other) |
| Locations | 1 site (Arnhem, Gelderland) |
| Trial ID | NCT05565456 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on understanding the biological remodeling process of intercorporal bone grafts used in lumbar spinal fusion surgery. It aims to assess the changes in bone mineral density over time using CT-based Hounsfield Units as a proxy for evaluating fusion status. By analyzing the remodeling of autologous bone grafts, the study seeks to provide insights into the effectiveness of spinal fusion techniques and the potential complications associated with non-union. The research will involve patients who have undergone lumbar fusion for specific spinal conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 45 to 80 who have not responded to non-operative treatment and require fusion for a single segment in the lumbar region.
Not a fit: Patients undergoing revision spine surgery or those who are pregnant or unwilling to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved assessment methods for spinal fusion outcomes, potentially reducing complications and enhancing patient recovery.
How similar studies have performed: While there is limited data on the specific approach of this study, similar studies have explored bone remodeling in spinal fusion with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Arnhem, Gelderland
- Rijnstate Hospital — Arnhem, Gelderland, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Job LC van Susante, Dr. PhD. — Rijnstate ziekenhuis
- Study coordinator: Joey FH Reijmer, Drs.
- Email: JReijmer@rijnstate.nl
- Phone: 088 - 005 7744
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spondylolisthesis, Spinal Fusion, Bone Density, Bone Remodelling, Tomography, X-Ray Computed