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The prospective evaluation of changes in the sagittal profile and the mobility of the spinal sections after mono- and bisegmental lumbar spinal fusion surgery using three-dimensional X-ray (EOS) and standardized motion analysis model

The prospective evaluation of changes in the sagittal profile and the mobility of the spinal sections after mono- and bisegmental lumbar spinal fusion surgery using three-dimensional X-ray (EOS) and standardized motion analysis model

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00020270
Enrollment
30
Registered
2020-02-13
Start date
2021-01-22
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M47

Interventions

Group 1: Patients with a degenerated lumbar spine at the age of 30-85 years and with an indication for mono- or bisegmental lumbar spinal fusion surgery: The primary variable is the change in pelvic m

Sponsors

Klinik für Unfallchirurgie und Orthopädie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 85 Years

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

MeasureTime 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

MeasureTime 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

Public ContactMarco Brenneis

Klinik für Unfallchirurgie und Orthopädie

brenneis@med.uni-frankfurt.de069-6705-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026