This study aims to evaluate the performance and safety of the Orthoss® as a bone graft extender in lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1).
This clinical investigation is a prospective, non-interventional, uncontrolled clinical trial, organized to generate clinical data on performance and safety of Orthoss® as a bone graft extender mixed with local bone at ratio of 1:1 and pedicle bone marrow aspirate in lumbar spondylodesis involving 1-2 levels. (Orthoss® is CE marked for this indication). If you as a patient have a wear and tear disease of the spine, an operation serves to restore the stability of the spinal column. In order to promote a bony build-up of the lumbar spine segment (fusion), bone replacement material is used in your case as standard. The aim of this observational study is to determine fusion in order to address clinical performance of that bone replacement material.
Study Type
OBSERVATIONAL
Enrollment
65
Orthoss® granules. Orthoss® granules mixed with local bone and pedicle bone marrow aspirate.
Universitätsklinikum Augsburg - Neurochirurgische Klinik und Poliklinik
Augsburg, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Klinikum Magdeburg gGmbH
Magdeburg, Germany
Fusion rate
Successful fusion should be based on the translational motion \< 3mm as well as on the angular motion \< 5° at 6 months.
Time frame: 6 months
Clinical Outcome Measure - Quality of Life: Oswestry Low Back Disability Index
Improvement in Oswestry Low Back Disability Index (ODI) of 15 or more at 24 months from the pre-operative value.Zero is equated with no disability and 100 is the maximum disability possible.
Time frame: 1-4 weeks; 3, 6, 12 and 24 months
Clinical Outcome Measure - Leg pain
Decrease in Visual Analog Scale for Pain (VAS) for leg by 3/10 or more at 24 months from the pre-operative value. Patients rated their leg pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score fo 10 representing "pain as bad as it could be".
Time frame: 1-4 weeks, 3,6,12 and 24 months
Clinical Outcome Measure - Back pain
Decrease in Visual Analog Scale for Pain (VAS) for back by 3/10 or more at 24 months from the pre-operative value. Patients rated their back pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score fo 10 representing "pain as bad as it could be".
Time frame: 1-
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