The primary objective of this clinical trial is to evaluate the success rates of Actifuse ABX and INFUSE in achieving bone fusion. The secondary objective of this clinical trial is to assess clinical outcome measurements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
bone substitute used for posterolateral instrumented lumbar fusion with interbody fusion
bone substitute in posterolateral instrumented lumbar fusion with interbody fusion
Moloney & Associates
Wollongong, Australia
Isala Klinik
Zwolle, Netherlands
Fusion, defined as evidence of bridging trabecular bone present at 1 year as assessed by CT scan as well as a determination of no motion as assessed by plain radiographs.
Time frame: 1 year
Improvement clinical outcomes measurements compared to pre-opscores: pain/Disability as measured by Oswestry Lower Back Pain Questionnaire, quality of Life as measured by Short Form Health Survey (SF36), and neurological status
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.