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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

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.

Condition or disease Intervention/treatment Phase
Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis) Procedure: Decompression Procedure: PLIF Procedure: MIS TLIF Procedure: Screw Fixation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
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
Official Title: Prospective Comparative Study of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine
Actual Study Start Date : November 15, 2018
Actual Primary Completion Date : February 15, 2019
Actual Study Completion Date : February 15, 2020

Arm Intervention/treatment
Experimental: Minimally invasive fusion
Bilateral decompression using unilateral approach, MIS TLIF + screw fixation percutaneous
Procedure: Decompression
Bilateral decompression

Procedure: MIS TLIF
On the one side - Wiltse approach, on the other side - percutaneous

Procedure: Screw Fixation
Transpedicular Screw Fixation

Active Comparator: Open Fusion
Bilateral decompression, open fusion + screw fixation
Procedure: Decompression
Bilateral decompression

Procedure: PLIF
Traditional open surgery

Procedure: Screw Fixation
Transpedicular Screw Fixation




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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


  2. 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


  3. Surgery duration [ Time Frame: Day of surgery ]
    Surgery duration, in minutes

  4. Blood loss [ Time Frame: Day of surgery ]
    Blood loss, in milliliter

  5. 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

  6. Bone fusion [ Time Frame: 12 months ]
    Intervertebral bone fusion formation, in degree (I, II, III or IV degree according to Tan)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT03748277


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
Investigators
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Principal Investigator: Aleksandr V Krutko, PhD, MD Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan, Neurosurgery Department
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Responsible Party: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
ClinicalTrials.gov Identifier: NCT03748277    
Other Study ID Numbers: 15/11/18
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan:
intraoperative procedures
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases