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

NCT04408846 | Withdrawn FDA Device

• 1 other identifier: NS02-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Intervertebral Disc Degeneration; Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change from baseline in Oswestry Disability Index (ODI)

  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

• Change from baseline in Douleur Neuropathique 4 (DN4)

  Through 2 years

• Change from baseline in The Health Transition Item from SF-36 (HTI Item)

  Through 2 years

Study Arms (2)

Minimally invasive lumbar fusion

OTHER

Device: Lumbar fusion

Open posterior lumbar fusion

OTHER

Device: Lumbar fusion

Interventions

Lumbar fusion DEVICE

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.

Minimally invasive lumbar fusion; Open posterior lumbar fusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

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

Novosibirsk, 630091, Russia

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 29, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2023
• Last Updated: September 11, 2020

Record last verified: 2020-05

Locations

RU (1)