M47
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with at least one of the following radiologically proven diagnoses: Degenerative changes in the lumbar spine (isolated or combined degeneration of the cortical structure, such as spondylarthrosis with consecutive spinal canal stenosis); Degenerative instabilities (formerly pseudo-spondylolisthesis); Conditions following nucleotomy or decompression in the sense of a post-nucleotomy syndrome. Age between 30 - 85 years. Indication and performance of mono- or bisegmental spondylodesis in the lumbar spine and lumbosacral in PLIF and TLIF technique (L3 - S1). Free standing and walking without assistance of aids.
Exclusion criteria
Exclusion criteria: • BMI =35 • Gear speed 1 cm • Endoprosthetics on the hip, knee or ankle • Surgery on the musculoskeletal system during the last 6 months • Spondylodesis • Destructive rheumatoid arthritis • Neurological disorders (e.g., Parkinson's disease, muscular dystrophy, epilepsy, multiple sclerosis, paraneoplastic neurological syndrome (PNS), tremor, Alzheimer's disease, Huntington's disease, polio, cerebral palsy) • Failed/lacking consent
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| As secondary variables additional kinematic and kinetic parameters (e.g. gait speed, step length, leaning forward of the trunk) are measured. As an additional secondary variable, the change of the sagittal profile after lumbar spinal fusion surgery will be determined using a three-dimensional X-ray (EOS). EOS is needed preoperatively to determine the sagittal profile and plan the surgery. Furthermore, it will allow us to more accurately determine the individual spinal column sections and their interaction with the pelvis. To assess hip and knee joint compensation mechanisms as well as their influence on the spinal stability, the lower limb is included in the study. To determine the postoperative sagittal profile, another EOS scan will be performed 6 months after operation. Finally, the overall health status and level of pain is assessed through questionnaires EQ-5D, ODI and VAS preoperatively and during a postoperative clinical follow-up 3, 6 and 12 months after the operation. We plan to include 30 patients in total. In particular, we aim to test whether fusion of the lumbar spine has a functional impact on typical everyday movements and / or gait as well as the sagittal profile of the total spinal column. Especially the analysis of the balance of the spine is of high clinical importance and scientific interest. The comparison of radiological parameters (EOS) with the results of the gait analysis could offer an important contribution to an improved clinical outcome after spinal lumbar fusion surgery. | — |
Primary
| Measure | Time frame |
|---|---|
| The primary variable is the change in pelvic movement in the sagittal plane (pelvic tilt) while walking after spinal fusion surgery of the lumbar spine. This is tested before and six months after the operation through an instrumental gait analysis using the VICON infrared camera system and the AMTI force plate. The mobility of the upper body is quantified using light-reflecting markers and the infrared camera system. We plan to include 30 patients in total. In particular, we aim to test whether fusion of the lumbar spine has a functional impact on typical everyday movements and / or gait as well as the sagittal profile of the total spinal column. Especially the analysis of the balance of the spine is of high clinical importance and scientific interest. | — |
Countries
Germany
Contacts
Klinik für Unfallchirurgie und Orthopädie