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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04408846
Recruitment Status : Not yet recruiting
First Posted : May 29, 2020
Last Update Posted : May 29, 2020
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Intervertebral Disc Degeneration Lumbar Spinal Stenosis Device: Lumbar fusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change from baseline in Oswestry Disability Index (ODI) [ Time Frame: Through 2 years ]
    To observe the change of ODI as compared to baseline through follow-up terms

  2. Change from baseline in Numeric Pain Rating Score (NPRS) [ Time Frame: Through 2 years ]
    To observe the change of NPRS as compared to baseline through follow-up terms

  3. Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D) [ Time Frame: Through 2 years ]
    To observe the change of EQ-5D as compared to baseline through follow-up terms

  4. Change from baseline in Douleur Neuropathique 4 (DN4) [ Time Frame: Through 2 years ]
    To observe the change of DN4 as compared to baseline through follow-up terms

  5. Change from baseline in The Health Transition Item from SF-36 (HTI Item) [ Time Frame: Through 2 years ]
    To observe the change of HTI Item through follow-up terms

  6. Change from baseline in Clinical Global Impression Of Change (CGIC) scale [ Time Frame: Through 2 years ]
    To observe the change of CGIC through follow-up terms

  7. Fusion rate success [ Time Frame: 12 months and 24 months post op ]
    Interbody fusion rate on CT based on Tan grades

  8. Cost-effectiveness [ Time Frame: 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.

  9. Adverse Events [ Time Frame: Through 2 years ]
    Document Adverse Events (incl. adverse events related to device) occurrence throughout the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04408846


Contacts
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Contact: Aleksandr V Krutko, PhD, MD +7(383)3733201 ext 1425 ortho-ped@mail.ru

Locations
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Russian Federation
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Novosibirsk, Russian Federation, 630091
Sponsors and Collaborators
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Medtronic
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Responsible Party: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
ClinicalTrials.gov Identifier: NCT04408846    
Other Study ID Numbers: NS02-01
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020

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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
Additional relevant MeSH terms:
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Spinal Stenosis
Intervertebral Disc Degeneration
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases