M51.1 M47.26
Conditions
Interventions
Group 1: Each of 25 patients will walk approximately 25 meters without any assistive devices. Characteristics of patient´s gait will be captured by means of a three-dimensional motion analysis system.
Sponsors
Orthopädisches Spital Speising
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: - Age between 20 and 70 years - Male and female patients - Signes informed consent - first-time, elective transforaminale lumbar inter body fusion (TLIF) across one to three motion segments
Exclusion criteria
Exclusion criteria: Pre-operative exclusion criteria: - Age under 20 or over 70 years - Pregnant and breastfeeding women. Women of childbearing age are allowed to participate if and only if a medical doctor has prospectively confirmed by means of a pregnancy test that the woman is not pregnant. - Central neurological disorders, e.g. Mb. Parkinson, encephalomyelitis disseminata, disorders of the cerebellum, Stroke, intracranial lesions - preexisting lumbar spondylodesis - systemic inflammatory rheumatic diseases that affect the spine - Other inflammatory diseases of the lumbar spine - acute fractures of thoracolumbar spine, the pelvis or the hip - Diagnosed psychiatric disorders, e.g. dementia or other cognitive impairments - Ongoing litigation due to spinal pain Post-operative exclusion criteria: - Wound infection - Immobility after surgery, that is, patient did not walk between day 2 and day 4 after TLIF surgery - Severe pain that makes it impossible for the patient to walk more than 100 meters
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following primary endpoints will be collected: 1.) Sagittal kinematic parameters of the trunk (forward and backward tilting of the trunk) 2.) Frontal kinematic parameters of the trunk (side bending of the trunk to the right and left) Both primary endpoints will be recorded during instrumented gait analysis for all four conditions and for each patient. Data collection will take approximately 45 minutes for each patient. It is performed by means of a three-dimensional motion analysis system. For this purpose 50 passive markers will be attached to standardized anatomic landmarks on the skin of patients. These markers will be captured by 12 infrared cameras at 150 Hz. Joint angles in all three planes of motion will be calculated from these data. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary endpoints will be collected: 1.) Time-distance parameters 2.) Rotational movements of the trunk 3.) Written record which assistive device was used during the first postoperative days 4.) Preferred assistive device (numeric rating scale) The secondary endpoints "time-distance-parameters" and "rotational movements of the trunk" will be collected during instrumented gait analysis for each of the four conditions and for each patient. Data collection will take approximately 45 minutes for each patient. It is performed by means of a three-dimensional motion analysis system. For this purpose 50 passive markers will be attached to standardized anatomic landmarks on the skin of patients. These markers will be captured by 12 infrared cameras at 150 Hz. Time-distance-parameters and joint angles in the transverse plane of motion will be calculated from these data. The other two secondary endpoints, "written record which assistive device was used during the first postoperative days" and "preferred assistive device (numeric rating scale)", will be collected by means of a standardized data sheet (case report form). Documentation will take place immediately after instrumented gait analysis, that is, immediately after the primary endpoints will have been collected. | — |
Countries
Austria
Contacts
Public ContactChristoph Thalhamer
Orthopädisches Spital Speising
Outcome results
None listed