Table 1 Primary and secondary outcome parameters
Outcome parameters | Assessments |
|---|---|
Primary outcome parameter | Oswestry Disability Index (ODI) at 2-year follow up to measure degenerative lumbar spondylolisthesis-related disability [8] |
Secondary outcome parameter | Questionnaire - Timed “Up and Go” test (TUG) [12] - Beck depression inventory (BDI) [10] - Changes in physical and mental health captured by the Short Form (SF)-12v2 [9] - Core outcome measure index (COMI) [30, 31], patient-orientated outcome questionnaire including - visual analog scale (VAS) for back and leg pain - patient’s satisfaction - work disability - social disability - Pain relief on 100-mm VAS for back pain and leg pain - PainDetect Questionnaire (PD-Q) [11] - EuroQoL 5-Dimension (EQ-5D) [9] |
Intraoperative - loss of blood (LOB) - amount of blood transfusion - operative time - length of wound incision - type of wound closure | |
Various - duration of hospitalization - device-related complications - surgery-related complications - re-operations - adverse events (AE), severe adverse events (SAE) | |
Health care contacts | |
Pain medication usage | |
Hospital costs | |
Radiological evaluation - x-ray evaluation (antero-posterior, lateral, flexion and extension, standing for overall sagittal alignment and differences in lordosis) - CT scan (overall fusion rate, rate of radiological and/or symptomatic adjacent segment disease, rate of pedicle and/or cage system implant failures) | |
Serum markers (CRP, leukocytes, TNF-α, IL-6) |