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

Not Applicable

Terminated

• Conditions: Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)
• Interventions: Procedure: Decompression; Procedure: PLIF; Procedure: MIS TLIF; Procedure: Screw Fixation

• Registration Number: NCT03748277
• Lead Sponsor: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-15
• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-11-17
• Study First Posted: 2018-11-20
• Primary Completion: 2019-02-15
• Status Verified: 2020-02
• Study Completion: 2020-02-15
• Last Update Submitted: 2020-05-12
• Last Update Posted: 2020-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open Fusion	PLIF	Bilateral decompression, open fusion + screw fixation
Minimally invasive fusion	MIS TLIF	Bilateral decompression using unilateral approach, MIS TLIF + screw fixation percutaneous
Open Fusion	Screw Fixation	Bilateral decompression, open fusion + screw fixation
Minimally invasive fusion	Decompression	Bilateral decompression using unilateral approach, MIS TLIF + screw fixation percutaneous
Minimally invasive fusion	Screw Fixation	Bilateral decompression using unilateral approach, MIS TLIF + screw fixation percutaneous
Open Fusion	Decompression	Bilateral decompression, open fusion + screw fixation

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	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 Outcome Measures

Name	Time	Method
Bone fusion	12 months	Intervertebral bone fusion formation, in degree (I, II, III or IV degree according to Tan)
MRI capacity spine canal	Day of hospital discharge (10-15 day after surgery)	Changes of spine canal capacity of spine segment, in sq. cm., as compared to baseline
Surgery duration	Day of surgery	Surgery duration, in minutes
Oswestry Disability Index (ODI)	3, 6 and 12 months	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 as compared to baseline
VAS (back, leg)	Day of hospital discharge (10-15 day after surgery), 3, 6 and 12 months	Visual Analogue Scale (VAS) - patient-reported pain intensity (0 - no pain, 10 - unbearable pain).; Improvement of VAS back- and leg pain intensity as compared to baseline
Blood loss	Day of surgery	Blood loss, in milliliter

Trial Locations

Locations (1)

Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan; 🇷🇺 Novosibirsk, Russian Federation