displacement of a lumbar vertebra Spondylolisthesis
Conditions
Interventions
Transforaminal lumbar interbody fusion (TLIF) compared to posterior lumbar
interbody fusion (PLIF).
Sponsors
Zuyderland Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Indication for TLIF (transforaminal lumbar interbody fusion) of PLIF (posterior lumbar interbody fusion) surgery. 2. Clinical mono uni-or bilateral lumbar radiculopathy or intermittent neurogenic claudication caused by a single level isthmic, degenerative or iatrogenic spondylolisthesis gr I, II or III according to Meyerding classification at level L3L4, L4L5 or L5S1. 3. Age over 18 years. 4. Single level spondylolisthesis with central or foraminal stenosis on MRI (or CT), of which the anatomical level is corresponding to the clinical syndrome. 5. Psychosocially, mentally, and physically able to fully comply with this study protocol. 6. Informed consent prior to this study., Inclusioncriteria of informal caregivers of patients: 1. The patient where the ICG offers his care, has to participate in the LIFT-study. 2. Age over 18 years 3. Psychosocially, mentally, and physically able to fully comply with this study protocol. 4. Informed consent prior to this study.
Exclusion criteria
Exclusion criteria: 1. Previous radiotherapy at the intended surgical level. 2. (Progressive) motor failure and/or anal sphincter disorders which urges instant intervention. 3. Active spinal infection. 4. Immature bone (on-going growth). 5. Active malignancy. 6. Pregnancy. 7. Symptomatic osteoporosis (based on DEXA-scan). 8. Contra-indications for anaesthesia or surgery. 9. Inadequate command of the Dutch language., Exclusioncriteria of informal caregivers of patients: 1. Inadequate command of the Dutch language.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine change in Oswestry Disability Index. This can be obtained by completing the ODI-questionnaire pre- and postoperatively. This functional score is a tool for measuring patients permanent functional disability, specially designed for patients with low back related disabilities. To determine change in quality of life adjusted years (QALY) with EQ-5D-5L, measured pre- and postoperatively. The EQ-5D-5L is a questionnaire to determine the quality-adjusted life years associated with a health state. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Hospital Anxiety Depression Scale (HADS): To determine the pre-operative anxiety and depression level with the use of HADS, a fourteen item scale, consisting of a 7-item depression scale and a 7-anxiety scale. The score range from 0-21 with a high score being indicative for depression/anxiety. - Short Form (36) Health Survey: To determine change in a patient-reported survey of patient health (physical and social status) consisting of 8 domains: Physical functioning, physical role functioning, emotional role functioning, vitality, mental health, social functioning, bodily pain and general health perceptions. Each domain is scored on a 0-100 scale, the higher the score the less disability. - Visual Analogue Scale (VAS) score of back pain and leg pain: To determine change in back and leg pain assessed on a horizontal 10 cm visual scale, varying from 0 cm (no pain) to 10 cm (worst pain imaginable). - To compare the number and kind of complications (defined as; dural tear, postoperative infection, hematoma, hardware failure, neurological deficits, medical other complications as pneumonia or urinary tract infection) between both procedures, peri- and postoperatively. - To determine clinical outcome by pre-operative and postoperative physical examination. Muscle strength of the legs classified with the MRC scale, sensibility in dermatomes classified into normally present, changed and absent, reflexes in the lower extremities. - Cost effectivity of both procedures determined with productivity related costs(iPCQ) and medical costs(iMCQ).* | — |
Countries
Netherlands
Outcome results
None listed