spinal canal stenosis
Conditions
Interventions
Investigational treatment
A. MITLIF group. After receiving antibiotic prophylaxis, the patient is brought
under general anaesthesia and positioned in prone position. Tubular retractors
are used to
Sponsors
Zuyderland Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Indication for MITLIF (minimal invasive transforaminal lumbar interbody fusion) or OTLIF (open transforaminal lumbar interbody fusion) surgery. - Clinical mono uni- or bilateral lumbar radiculopathy or intermittent neurogenic claudication caused by a single level degenerative foraminal stenosis or isthmic, iatrogenic, or degenerative spondylolisthesis gr I or II according to Meyerding classification at level L3L4, L4L5 or L5S1. - Age over 18 years. - Single level degenerative foraminal stenosis or isthmic, iatrogenic, or degenerative spondylolisthesis causing central stenosis on MRI (or CT), of which the anatomical level is corresponding to the clinical syndrome. - Psychosocially, mentally, and physically able to fully comply with this study protocol. - Informed consent prior to this study.
Exclusion criteria
Exclusion criteria: - Previous radiotherapy at the intended surgical level. - (Progressive) motor failure and/or anal sphincter disorders which urges instant intervention. - Active spinal infection. - Immature bone (on-going growth). - Active malignancy. - Pregnancy. - Symptomatic osteoporosis (Current or previous use of bisphosphonates). - Contra-indications for anaesthesia or surgery. - Inadequate command of the Dutch language.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in quality-adjusted life years (QALY) measured with EQ-5D-5L. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cost-effectiveness measured using the productivity related costs (iPCQ), informal care costs (limited iVICQ) and medical costs (iMCQ). Quality of life measured using the following PROMs: Oswestry Disability Index (ODI), Short Form (36) Health Survey (SF-36), Visual Analogue Scale (VAS) score of back pain and leg pain and Hospital Anxiety Depression Scale (HADS). Complications as a result of surgery, are defined as: dural tear, postoperative infection, deep venous thrombosis, hematoma, hardware failure, neurological deficits and other complications as pneumonia or urinary tract infection. Care-related Quality of life measured using the CarerQol-7D and SRB, included in the limited Valuation of Informal Care Questionnaire (iVICQ). Process evaluation will be performed according to the framework provided by Saunders (19). Interviews will be held with randomly chosen patients and ICG, and the principal investigator to collect qualitative data. Other study parameters Other study parameters are: sex, age, BMI, smoking habits, occurrence of diabetes, diagnosis, level, grade of spondylolisthesis, previous back surgery and ASA classification. Also, perioperative morbidity, assessed with: duration of surgery, intraoperative blood loss, duration of hospitalization. | — |
Countries
Netherlands
Outcome results
None listed