Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion
Not Applicable
- Conditions
- Spinal Fusion
- Registration Number
- NCT03692845
- Lead Sponsor
- Assiut University
- Brief Summary
A study that compares between Open TLIF and Minimally invasive TLIF regarding patients' functional status(Oswestry Disability index)as a primary outcome measure.
- Detailed Description
The first randomized controlled trial comparing minimally invasive TLIF and open TLIF.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Adults more than 18 years of age and less than 65 years of age..
- Degenerative or isthmic spondylolithesis Grade 1,2 and 3.
- Recurrent Symptomatic recurrent lumbar disc prolapsed with or without evident neural compression.
- Single level pathology involving L2-3, L3-4, L4-5 and or L5-S1.
- Symptoms not responding to conservative treatment for at least 3 months.
Exclusion Criteria
- Previous spinal fusion or instrumentation.
- Spinal tumours, infection and fractures.
- Patients with severe osteoporosis
- BMI more than 35.
- Non-ambulant patients and patients with severe preoperative neurological affection (Cauda Equina Syndrome)
- Patients not willing to participate in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Oswestry Disability index(Arabic version) 1 month 1 month an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.
- Secondary Outcome Measures
Name Time Method • Fusion rate as assessed by Bridwell fusion score. 1 year Grade I is defined as fusion with remodelling and trabeculae present; Grade II is an intact graft with incomplete remodelling and no lucency present; Grade III is an intact graft with potential lucency at the cranial or caudal end; Grade IV is absent fusion with collapse/resorption of the graft.