Prospective Comparative Study of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)
- Sponsor
- Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Oswestry Disability Index (ODI)
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the clinical and radiological results of surgical treatment of one-level central stenosis of the lumbar spine using traditional open approach (PLIF) and a minimally invasive procedure (MIS TLIF). According to the hypothesis, we assume that unilateral approach of MIS TLIF allows for adequate bilateral decompression of one-level central stenosis of the lumbar spine. Using MIS TLIF it is possible to perform reliable fixation of a spine segment and the formation of a complete intervertebral bone fusion. The long-term clinical results of surgical treatment with minimally invasive technologies (MIS TLIF) and traditional open approach (PLIF) suspected to be comparable.
Investigators
Eligibility Criteria
Inclusion Criteria
- •syndrome of mono- or polyradicular compression of the nerve roots with / without a reflex pain syndromes, caused by stenosis of one lumbar spine segment;
- •intermittent claudication caused by stenosis of one lumbar spine segment;
- •one-level spine stenosis in combination with local segment instability or degenerative spondylolisthesis at the same spine segment, requiring fusion in only one lumbar segment
Exclusion Criteria
- •bilateral foraminal lumbar spine stenosis;
- •lumbar spine stenosis more than one-level;
- •spondylolisthesis II degree and more;
- •sagittal imbalance;
- •fusion the same lumbar spine segment after surgery previously;
- •other diseases of the spine, including trauma, tumor and inflammatory diseases of the lumbar spine, etc.
Outcomes
Primary Outcomes
Oswestry Disability Index (ODI)
Time Frame: Day of hospital discharge (10-15 day after surgery)
Oswestry Disability Index - patient-reported physical and household activity. Minimum - 0 (the worst result, patient is not physically active). Maximum - 50 (the best result). Improvement of ODI post-operatively as compared to baseline
Secondary Outcomes
- Bone fusion(12 months)
- MRI capacity spine canal(Day of hospital discharge (10-15 day after surgery))
- Surgery duration(Day of surgery)
- Oswestry Disability Index (ODI)(3, 6 and 12 months)
- VAS (back, leg)(Day of hospital discharge (10-15 day after surgery), 3, 6 and 12 months)
- Blood loss(Day of surgery)