Clinical trial NCT03748277: Comparison of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine
Official title: Prospective Comparative Study of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)
Keywords: intraoperative procedures
Lead sponsor: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Sponsor class: OTHER_GOV
First posted: 2018-11-20
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. group - decompression, MIS TLIF + Screw Fixation
2. group - decompression, open fusion + Screw Fixation
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: Day of hospital discharge (10-15 day after surgery)
Secondary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 3, 6 and 12 months
measure: VAS (back, leg)
timeFrame: Day of hospital discharge (10-15 day after surgery), 3, 6 and 12 months
measure: Surgery duration
timeFrame: Day of surgery
measure: Blood loss
timeFrame: Day of surgery
measure: MRI capacity spine canal
timeFrame: Day of hospital discharge (10-15 day after surgery)
measure: Bone fusion
timeFrame: 12 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Study officials:
affiliation: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan, Neurosurgery Department
name: Aleksandr V Krutko, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: