Minimally Invasive Surgery Versus Traditional Open Surgery In The Treatment Of Single Level Lumbar Stenosis

An Open-Label Randomized Controlled Study of the Efficacy of Surgical Treatment in Patients With Single Level Lumbar Spinal Stenosis Using Minimally Invasive Surgery and Traditional Open Surgical Procedure

The purpose of this study is to determine the effectiveness of minimally invasive surgical technique over the traditional open surgical procedure in patients with degenerative lumbar stenosis

Study Overview

• Status: Withdrawn
• Conditions: Intervertebral Disc Degeneration; Lumbar Spinal Stenosis
• Intervention / Treatment: Device: Lumbar fusion

• Study Type: Interventional
• 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: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 to 75 years;
• Patient has single level degenerative lumbar spinal stenosis and an indication for a single level instrumented lumbar fusion for the treatment;
• Symptoms persisting for at least three months prior to surgery;
• Given written Informed Consent;
• Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.

Exclusion Criteria:

• Prior lumbar spinal fusion at any level;
• Other non-degenerative spinal conditions (e.g. infectious, traumatic, metabolic, inflammatory, neoplastic, structural or other pathology) that may have an impact on subject safety, wellbeing or the intent and conduct of the study;
• Any condition that cannot be treated with mini-invasive unilateral decompression and fusion;
• History or presence of any other major neurological disease or condition that may interfere with the study assessments (e.g. significant peripheral neuropathy, multiply sclerosis);
• Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Minimally invasive lumbar fusion	Device: Lumbar fusion; Patients will receive a single level instrumented fusion using a minimally invasive or open traditional surgical procedure with a posterior fixation. For the use of a posterior fixation system, the CD Horizon® Spinal System, is mandatory in this study and will be either minimally invasive or open.
Other: Open posterior lumbar fusion	Device: Lumbar fusion; Patients will receive a single level instrumented fusion using a minimally invasive or open traditional surgical procedure with a posterior fixation. For the use of a posterior fixation system, the CD Horizon® Spinal System, is mandatory in this study and will be either minimally invasive or open.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Oswestry Disability Index (ODI)	To observe the change of ODI as compared to baseline through follow-up terms	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness	Total cost of surgical procedure (implanted system, the salary for surgery team) and the cost of patient's staying at the clinic before discharge.	14th day of hospital stay
Fusion rate success	Interbody fusion rate on CT based on Tan grades	12 months and 24 months post op
Adverse Events	Document Adverse Events (incl. adverse events related to device) occurrence throughout the study	Through 2 years
Change from baseline in Oswestry Disability Index (ODI)	To observe the change of ODI as compared to baseline through follow-up terms	Through 2 years
Change from baseline in Numeric Pain Rating Score (NPRS)	To observe the change of NPRS as compared to baseline through follow-up terms	Through 2 years
Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D)	To observe the change of EQ-5D as compared to baseline through follow-up terms	Through 2 years
Change from baseline in Douleur Neuropathique 4 (DN4)	To observe the change of DN4 as compared to baseline through follow-up terms	Through 2 years
Change from baseline in The Health Transition Item from SF-36 (HTI Item)	To observe the change of HTI Item through follow-up terms	Through 2 years
Change from baseline in Clinical Global Impression Of Change (CGIC) scale	To observe the change of CGIC through follow-up terms	Through 2 years

Collaborators and Investigators

• Sponsor: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: NS02-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes