Some people have back problems caused by degenerative conditions or instability of the spine (eg. Spondylolisthesis). These problems can lead to pain, nerve issues, or difficulties in walking. A common treatment is a type of back surgery called lumbar interbody fusion, which helps stabilize the spine.
At the St. Maartenskliniek in the Netherlands, doctors have been using a special material called Fibergraft Bioactive Glass Putty for such surgeries since 2023. This material helps bones grow and heal, and it's placed inside the spine without needing extra bone from another part of the body.
This study will look at how well this material works by evaluating how many patients' bones successfully healed after surgery using this material. It will also look at how patients feel and recover after the procedure
Adults ≥ 18 years old
Diagnosed with the following lumbar spine disorders: foraminal nerve root compression, isthmic spondylolisthesis, and short-segment (1-2 levels) deformity.
ALIF (up to 2 levels) as either standalone (ie, no posterior procedure) or as an anterior first procedure with posterior procedure as a second procedure.
XLIF (up to 2 levels) as an anterior first procedure with posterior procedure as a second procedure.
Revision surgery
Standalone XLIF
Posterior lumbar interbody fusion
Diagnosis of fractures, malignancies, ankylosing spondylitis, or acute cauda equina syndrome
Patients with spinal degenerative deseases from the St Mateenskliniek
Cohort
Prospective
Questionnaires
BehavioralQuestionnaires * Oswestry Disability Index (ODI) * Pain NRS lower back and (wors side) leg * EQ-5D-3L
Computer Tomography
RadiationOne additional CT scan is performed for some patients
Interbody fusion status
The primary outcome measure is the interbody fusion status determined by a regular lumbar spine CT scan protocol without additional radiation or contrast agents. The patients will be evaluated with one CT-scan within a window of 12 to 24 months postsurgery. The Bridwell Interbody Fusion Grading Classification will be used to assess fusion status for each intended segment.
Oswestry Disability Index (ODI)
The level of disability will be measured using the ODI . The ODI is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, with 5 representing the greatest disability. The index is calculated by dividing the sum of the scores by the total possible score, which is then multiplied by 100 and expressed as a percentage. The preoperative ODI will be retrospectively collected via medical records, and patients will fill out the ODI at the 12-24 months visit.
General back pain and (worse side) leg pain
General back pain and (worse side) leg pain will be measured by the patients on an NRS of 0 to 10, with 0 representing no pain and 10 the worst imaginable pain. Preoperative pain NRS will be retrospectively collected via medical records, and patients will fill out pain NRS at the 12-24 months visit.
The EuroQoL-5 Dimension
The EQ-5D is a generic measure of self-reported health developed by the EuroQol Group. It measures five dimensions for describing health states: mobility, usual activities, self-care, pain and discomfort, and anxiety and depression. The questionnaire is comprised of two parts. The first part is the EQ-5D descriptive system, in which individuals are asked to indicate the level of problem they experience on each of the five dimensions. The second part is the EQ Visual Analogue Scale, which captures the individual's overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable). For this study, the EQ-5D-3L (3 levels) version will be used. Preoperative EQ-5D-3L will be retrospectively collected via medical records, and patients will fill out EQ-5D-3L at the 12-24 months visit.
Patient's overall satisfaction
Patients' overall satisfaction with the treatment will be measured on a 7-point Likert scale at the 12-24 months visit. * Extremely satisfied * Very satisfied * Somewhat satisfied * Mixed (approximately equal satisfaction and dissatisfaction) * Somewhat dissatisfied * Very dissatisfied * Extremely dissatisfied
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
