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

Primary Purpose

Intervertebral Disc Degeneration, Lumbar Spinal Stenosis

Status
Withdrawn
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Lumbar fusion
Sponsored by
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intervertebral Disc Degeneration

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Minimally invasive lumbar fusion

Open posterior lumbar fusion

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in Oswestry Disability Index (ODI)
To observe the change of ODI as compared to baseline through follow-up terms
Change from baseline in Numeric Pain Rating Score (NPRS)
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)
To observe the change of EQ-5D as compared to baseline through follow-up terms
Change from baseline in Douleur Neuropathique 4 (DN4)
To observe the change of DN4 as compared to baseline through follow-up terms
Change from baseline in The Health Transition Item from SF-36 (HTI Item)
To observe the change of HTI Item through follow-up terms
Change from baseline in Clinical Global Impression Of Change (CGIC) scale
To observe the change of CGIC through follow-up terms
Fusion rate success
Interbody fusion rate on CT based on Tan grades
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.
Adverse Events
Document Adverse Events (incl. adverse events related to device) occurrence throughout the study

Full Information

First Posted
May 20, 2020
Last Updated
September 9, 2020
Sponsor
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT04408846
Brief Title
Minimally Invasive Surgery Versus Traditional Open Surgery In The Treatment Of Single Level Lumbar Stenosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
The Study will be conducted in another research center. The Sponsor has changed.
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Collaborators
Medtronic

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervertebral Disc Degeneration, Lumbar Spinal Stenosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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