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

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.

Study Overview

• Status: Terminated
• Conditions: Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)
• Intervention / Treatment: Procedure: Decompression; Procedure: MIS TLIF; Procedure: Screw Fixation; Procedure: PLIF

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630091
    • Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Minimally invasive fusion; Bilateral decompression using unilateral approach, MIS TLIF + screw fixation percutaneous	Procedure: Decompression; Bilateral decompression; Procedure: MIS TLIF; On the one side - Wiltse approach, on the other side - percutaneous; Procedure: Screw Fixation; Transpedicular Screw Fixation
Active Comparator: Open Fusion; Bilateral decompression, open fusion + screw fixation	Procedure: Decompression; Bilateral decompression; Procedure: Screw Fixation; Transpedicular Screw Fixation; Procedure: PLIF; Traditional open surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI)	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	Day of hospital discharge (10-15 day after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI)	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	3, 6 and 12 months
VAS (back, leg)	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	Day of hospital discharge (10-15 day after surgery), 3, 6 and 12 months
Surgery duration	Surgery duration, in minutes	Day of surgery
Blood loss	Blood loss, in milliliter	Day of surgery
MRI capacity spine canal	Changes of spine canal capacity of spine segment, in sq. cm., as compared to baseline	Day of hospital discharge (10-15 day after surgery)
Bone fusion	Intervertebral bone fusion formation, in degree (I, II, III or IV degree according to Tan)	12 months

Collaborators and Investigators

• Sponsor: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
• Investigators: Principal Investigator: Aleksandr V Krutko, PhD, MD, Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan, Neurosurgery Department

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Actual): February 15, 2019
• Study Completion (Actual): February 15, 2020

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: November 17, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: intraoperative procedures
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: 15/11/18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No