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

Not Applicable

Withdrawn

• Conditions: Intervertebral Disc Degeneration; Lumbar Spinal Stenosis
• Interventions: Device: Lumbar fusion

• Registration Number: NCT04408846
• Lead Sponsor: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-05-29
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-11
• Study Start: 2020-12-01
• Primary Completion: 2021-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open posterior lumbar fusion	Lumbar fusion	-
Minimally invasive lumbar fusion	Lumbar fusion	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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