Comparison of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine

Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan

Status: Terminated

Conditions: Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)

Treatments: Procedure: PLIF; Procedure: Decompression; Procedure: Screw Fixation; Procedure: MIS TLIF

Study type: Interventional

Funder types: Other

Identifiers

NCT03748277

15/11/18

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Minimally invasive fusion

Experimental group

Description:

Bilateral decompression using unilateral approach, MIS TLIF + screw fixation percutaneous

Treatment:

Procedure: Screw Fixation

Procedure: Decompression

Procedure: MIS TLIF

Open Fusion

Active Comparator group

Description:

Bilateral decompression, open fusion + screw fixation

Treatment:

Procedure: Screw Fixation

Procedure: PLIF

Procedure: Decompression