NCT03748277

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)

Interventions

Type	Name	Description
PROCEDURE	Decompression	Bilateral decompression
PROCEDURE	PLIF	Traditional open surgery
PROCEDURE	MIS TLIF	On the one side - Wiltse approach, on the other side - percutaneous
PROCEDURE	Screw Fixation	Transpedicular Screw Fixation

Timeline

• Start date: 2018-11-15
• Primary completion: 2019-02-15
• Completion: 2020-02-15
• First posted: 2018-11-20
• Last updated: 2020-05-14

Locations

1 site across 1 country: Russia