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

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ClinicalTrials.gov Identifier: NCT03748277
Recruitment Status : Terminated (Recruitment terminated, all follow-up visits were canceled due to quarantine)
First Posted : November 20, 2018
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan

Tracking Information
First Submitted Date  ICMJE November 15, 2018
First Posted Date  ICMJE November 20, 2018
Last Update Posted Date May 14, 2020
Actual Study Start Date  ICMJE November 15, 2018
Actual Primary Completion Date February 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
Oswestry Disability Index (ODI) [ Time Frame: Day of hospital discharge (10-15 day after surgery) ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2018)
Oswestry Disability Index (ODI) [ Time Frame: Day of hospital discharge (10-15 day after surgery) ]
Improvement of ODI post-operatively as compared to baseline
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • Oswestry Disability Index (ODI) [ Time Frame: 3, 6 and 12 months ]
    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) [ Time Frame: Day of hospital discharge (10-15 day after surgery), 3, 6 and 12 months ]
    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 [ Time Frame: Day of surgery ]
    Surgery duration, in minutes
  • Blood loss [ Time Frame: Day of surgery ]
    Blood loss, in milliliter
  • MRI capacity spine canal [ Time Frame: Day of hospital discharge (10-15 day after surgery) ]
    Changes of spine canal capacity of spine segment, in sq. cm., as compared to baseline
  • Bone fusion [ Time Frame: 12 months ]
    Intervertebral bone fusion formation, in degree (I, II, III or IV degree according to Tan)
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2018)
  • Oswestry Disability Index (ODI) [ Time Frame: 3, 6 and 12 months ]
    Improvement of ODI as compared to baseline
  • VAS (back, leg) [ Time Frame: Day of hospital discharge (10-15 day after surgery), 3, 6 and 12 months ]
    Improvement of VAS back- and leg pain intensity as compared to baseline
  • Sugery duration [ Time Frame: Day of surgery ]
    Sugery duration, in minutes
  • Blood loss [ Time Frame: Day of surgery ]
    Blood loss, in milliliter
  • MRI capacity spine canal [ Time Frame: 3 months ]
    Changes of spine canal capacity of spine segment, in sq. cm., as compared to baseline
  • Bone fusion [ Time Frame: 12 months ]
    Intervertebral bone fusion formation, in degree (I, II, III or IV degree according to Tan)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine
Official Title  ICMJE Prospective Comparative Study of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  1. group - decompression, MIS TLIF + Screw Fixation
  2. group - decompression, open fusion + Screw Fixation
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)
Intervention  ICMJE
  • Procedure: Decompression
    Bilateral decompression
  • Procedure: PLIF
    Traditional open surgery
  • Procedure: MIS TLIF
    On the one side - Wiltse approach, on the other side - percutaneous
  • Procedure: Screw Fixation
    Transpedicular Screw Fixation
Study Arms  ICMJE
  • Experimental: Minimally invasive fusion
    Bilateral decompression using unilateral approach, MIS TLIF + screw fixation percutaneous
    Interventions:
    • Procedure: Decompression
    • Procedure: MIS TLIF
    • Procedure: Screw Fixation
  • Active Comparator: Open Fusion
    Bilateral decompression, open fusion + screw fixation
    Interventions:
    • Procedure: Decompression
    • Procedure: PLIF
    • Procedure: Screw Fixation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 17, 2018)
132
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 15, 2020
Actual Primary Completion Date February 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03748277
Other Study ID Numbers  ICMJE 15/11/18
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Study Sponsor  ICMJE Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aleksandr V Krutko, PhD, MD Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan, Neurosurgery Department
PRS Account Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP