Displacement of vertebra in the spine spondylolisthesis
Conditions
Interventions
None listed
Sponsors
Rijnstate Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients are only eligible for participation if they i) were non-responsive to non-operative treatment in the six months prior to study enrolment, ii) have fusion indicated for only one segment in the L1 to S1/ilium region and iii) are between the age of 45 and 80.
Exclusion criteria
Exclusion criteria: Patients will be excluded from participation if they i) will receive revision spine surgery, ii) do not want to provide informed consent or when iii) pregnant or expecting to be pregnant within in the next two years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome of interest will be the participants* individual and group (mean, SD) Hounsfield Unit values of their intercorporal bone graft(s) as calculated from their (four) CT-scans. We will use the standardized HU measurement protocol developed during a feasibility study. The HU will be assessed independently by three observers. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include the Oswestry Low Back Pain Disability Questionnaire (ODI), Research and Development 36 (RAND-36), Visual Analogue Scale (VAS) for back and leg pain and the intercorporal fusion result criteria by Brantigan et al. | — |
Countries
Netherlands
Outcome results
None listed