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Comparison of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine

Primary Purpose

Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)

Status
Terminated
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Decompression
PLIF
MIS TLIF
Screw Fixation
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 health services research trial for Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis) focused on measuring intraoperative procedures

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • syndrome of mono- or polyradicular compression of the nerve roots with / without a reflex pain syndromes, caused by stenosis of one lumbar spine segment;
  • intermittent claudication caused by stenosis of one lumbar spine segment;
  • one-level spine stenosis in combination with local segment instability or degenerative spondylolisthesis at the same spine segment, requiring fusion in only one lumbar segment

Exclusion Criteria:

  • bilateral foraminal lumbar spine stenosis;
  • lumbar spine stenosis more than one-level;
  • spondylolisthesis II degree and more;
  • sagittal imbalance;
  • fusion the same lumbar spine segment after surgery previously;
  • other diseases of the spine, including trauma, tumor and inflammatory diseases of the lumbar spine, etc.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Minimally invasive fusion

Open Fusion

Arm Description

Bilateral decompression using unilateral approach, MIS TLIF + screw fixation percutaneous

Bilateral decompression, open fusion + screw fixation

Outcomes

Primary Outcome Measures

Oswestry Disability Index (ODI)
Oswestry Disability Index - patient-reported physical and household activity. Minimum - 0 (the worst result, patient is not physically active). Maximum - 50 (the best result). Improvement of ODI post-operatively as compared to baseline

Secondary Outcome Measures

Oswestry Disability Index (ODI)
Oswestry Disability Index - patient-reported physical and household activity. Minimum - 0 (the worst result, patient is not physically active). Maximum - 50 (the best result). Improvement of ODI as compared to baseline
VAS (back, leg)
Visual Analogue Scale (VAS) - patient-reported pain intensity (0 - no pain, 10 - unbearable pain). Improvement of VAS back- and leg pain intensity as compared to baseline
Surgery duration
Surgery duration, in minutes
Blood loss
Blood loss, in milliliter
MRI capacity spine canal
Changes of spine canal capacity of spine segment, in sq. cm., as compared to baseline
Bone fusion
Intervertebral bone fusion formation, in degree (I, II, III or IV degree according to Tan)

Full Information

First Posted
November 15, 2018
Last Updated
May 12, 2020
Sponsor
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
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1. Study Identification

Unique Protocol Identification Number
NCT03748277
Brief Title
Comparison of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine
Official Title
Prospective Comparative Study of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Recruitment terminated, all follow-up visits were canceled due to quarantine
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
February 15, 2019 (Actual)
Study Completion Date
February 15, 2020 (Actual)

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the clinical and radiological results of surgical treatment of one-level central stenosis of the lumbar spine using traditional open approach (PLIF) and a minimally invasive procedure (MIS TLIF). According to the hypothesis, we assume that unilateral approach of MIS TLIF allows for adequate bilateral decompression of one-level central stenosis of the lumbar spine. Using MIS TLIF it is possible to perform reliable fixation of a spine segment and the formation of a complete intervertebral bone fusion. The long-term clinical results of surgical treatment with minimally invasive technologies (MIS TLIF) and traditional open approach (PLIF) suspected to be comparable.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)
Keywords
intraoperative procedures

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
group - decompression, MIS TLIF + Screw Fixation group - decompression, open fusion + Screw Fixation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minimally invasive fusion
Arm Type
Experimental
Arm Description
Bilateral decompression using unilateral approach, MIS TLIF + screw fixation percutaneous
Arm Title
Open Fusion
Arm Type
Active Comparator
Arm Description
Bilateral decompression, open fusion + screw fixation
Intervention Type
Procedure
Intervention Name(s)
Decompression
Intervention Description
Bilateral decompression
Intervention Type
Procedure
Intervention Name(s)
PLIF
Intervention Description
Traditional open surgery
Intervention Type
Procedure
Intervention Name(s)
MIS TLIF
Intervention Description
On the one side - Wiltse approach, on the other side - percutaneous
Intervention Type
Procedure
Intervention Name(s)
Screw Fixation
Intervention Description
Transpedicular Screw Fixation
Primary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
Oswestry Disability Index - patient-reported physical and household activity. Minimum - 0 (the worst result, patient is not physically active). Maximum - 50 (the best result). Improvement of ODI post-operatively as compared to baseline
Time Frame
Day of hospital discharge (10-15 day after surgery)
Secondary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
Oswestry Disability Index - patient-reported physical and household activity. Minimum - 0 (the worst result, patient is not physically active). Maximum - 50 (the best result). Improvement of ODI as compared to baseline
Time Frame
3, 6 and 12 months
Title
VAS (back, leg)
Description
Visual Analogue Scale (VAS) - patient-reported pain intensity (0 - no pain, 10 - unbearable pain). Improvement of VAS back- and leg pain intensity as compared to baseline
Time Frame
Day of hospital discharge (10-15 day after surgery), 3, 6 and 12 months
Title
Surgery duration
Description
Surgery duration, in minutes
Time Frame
Day of surgery
Title
Blood loss
Description
Blood loss, in milliliter
Time Frame
Day of surgery
Title
MRI capacity spine canal
Description
Changes of spine canal capacity of spine segment, in sq. cm., as compared to baseline
Time Frame
Day of hospital discharge (10-15 day after surgery)
Title
Bone fusion
Description
Intervertebral bone fusion formation, in degree (I, II, III or IV degree according to Tan)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: syndrome of mono- or polyradicular compression of the nerve roots with / without a reflex pain syndromes, caused by stenosis of one lumbar spine segment; intermittent claudication caused by stenosis of one lumbar spine segment; one-level spine stenosis in combination with local segment instability or degenerative spondylolisthesis at the same spine segment, requiring fusion in only one lumbar segment Exclusion Criteria: bilateral foraminal lumbar spine stenosis; lumbar spine stenosis more than one-level; spondylolisthesis II degree and more; sagittal imbalance; fusion the same lumbar spine segment after surgery previously; other diseases of the spine, including trauma, tumor and inflammatory diseases of the lumbar spine, etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandr V Krutko, PhD, MD
Organizational Affiliation
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan, Neurosurgery Department
Official's Role
Principal Investigator
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

Comparison of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine

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