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

Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan1 site in 1 countryDecember 1, 2020

ConditionsIntervertebral Disc Degeneration Lumbar Spinal Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intervertebral Disc Degeneration
Sponsor: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Locations: 1
Primary Endpoint: Change from baseline in Oswestry Disability Index (ODI)
Status: Withdrawn
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

December 1, 2020

End Date

December 1, 2023

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Change from baseline in Oswestry Disability Index (ODI)

Time Frame: 3 months

To observe the change of ODI as compared to baseline through follow-up terms

Secondary Outcomes

Change from baseline in Douleur Neuropathique 4 (DN4)(Through 2 years)
Change from baseline in Numeric Pain Rating Score (NPRS)(Through 2 years)
Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D)(Through 2 years)
Fusion rate success(12 months and 24 months post op)
Change from baseline in The Health Transition Item from SF-36 (HTI Item)(Through 2 years)
Adverse Events(Through 2 years)
Change from baseline in Oswestry Disability Index (ODI)(Through 2 years)
Change from baseline in Clinical Global Impression Of Change (CGIC) scale(Through 2 years)
Cost-effectiveness(14th day of hospital stay)