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Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction

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ClinicalTrials.gov Identifier: NCT03908203
Recruitment Status : Withdrawn (The Study will be conducted in another research center. The Sponsor has changed.)
First Posted : April 9, 2019
Last Update Posted : September 11, 2020
Sponsor:
Collaborator:
DePuy International
Information provided by (Responsible Party):
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan

Study Description
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Brief Summary:

This study will be conducted at Research Institute of Traumatology and Orthopedics (NRITO) n.a. Ya.L.Tsivyan, Novosibirsk, Russia.

The current study is prospective pilot clinical study to demonstrate the possibility and effectiveness of performing modified technique of MIS TLIF, supplemented by segmental vertebrotomy, to correct segmental deformity of lumbar spine.

It is expected to enroll 10 patients aged 18-70 with segmental deformity of lumbar spine, caused by degenerative spondylolisthesis and/or degenerative stenosis.


Condition or disease Intervention/treatment Phase
Intervertebral Disc Degeneration Spinal Fusion Procedure: Minimally invasive one-level lumbar deformity correction Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Treatment Arm Procedure: Minimally invasive one-level lumbar deformity correction
The study treatment represents modified technique of MIS TLIF: one level screws fixation using Wiltse approach at one side, the other side - percutaneously, one level decompression, correction of segmental deformity by performing vertebrotomy and then intervertebral fusion.


Outcome Measures
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Primary Outcome Measures :
  1. Angle change at lumbar spine segment [ Time Frame: At 1 Day of hospital discharge or 14th day of hospital stay (depends on what event comes first) ]
    Angle between endplates at the treated level of lumbar spine


Secondary Outcome Measures :
  1. Improvement of Visual analog scale (VAS) back pain intensity [ Time Frame: 3, 6, 12 months ]

    To observe the improvement of VAS back pain as compared to baseline through follow-up terms.

    Visual Analogue Scale (VAS) - patient-reported pain intensity (0 - no pain, 10 - unbearable pain).


  2. Improvement of Visual analog scale (VAS) leg pain intensity [ Time Frame: 3, 6, 12 months ]

    To observe the improvement of VAS leg pain as compared to baseline through follow-up terms.

    Visual Analogue Scale (VAS) - patient-reported pain intensity (0 - no pain, 10 - unbearable pain).


  3. Improvement of Oswestry Disability Index (ODI) [ Time Frame: 3, 6, 12 months ]
    To observe the improvement of ODI as compared to baseline through follow-up terms Oswestry Disability Index - patient-reported physical and household activity. Minimum - 0 % (the best result, the patient has no limitations in physical activity). Maximum - 100% (the worst result, patient is not physically active at all).

  4. Fusion rate success [ Time Frame: 12 months ]

    To observe the Fusion rate (I, II, III or IV grade according to Tan).

    Grade I - complete fusion; Grade II - partial fusion; Grade III - unipolar pseudarthrosis; Grade IV - bipolar pseudarthrosis.


  5. Range of Motion [ Time Frame: At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months ]
    To observe the disc mobility at the treated level

  6. Sagittal balance parameters [ Time Frame: At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months ]
    To observe sagittal balance as compared to baseline

  7. Disc height [ Time Frame: At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months ]
    To observe disc height at the treated level as compared to baseline

  8. Blood loss [ Time Frame: Day of surgery ]
    Blood loss

  9. Surgery duration [ Time Frame: Day of surgery ]
    Surgery duration


Eligibility Criteria
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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:

  • Given written Informed Consent;
  • Single-level segmental deformity caused by degenerative spondylolisthesis and/or degenerative stenosis at the one level of lumbar spine L4-L5 or L5-S1;
  • Mono- and/or polyradicular leg pain and/or neurogenic claudication with or without back pain;
  • Symptoms persisting for at least three months prior to surgery;
  • Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.

Exclusion Criteria:

  • Lumbar deformation of non-degenerative etiology;
  • Spondylolisthesis grade II or higher (25% slip or greater) of any etiology;
  • Patient that has already undergone a lumbar fusion surgery;
  • 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
  • Concurrent participation in another clinical study that may confound study results.
Contacts and Locations
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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): NCT03908203


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
DePuy International
Investigators
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Principal Investigator: Aleksandr V Krutko, PhD, MD Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
More Information
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Responsible Party: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
ClinicalTrials.gov Identifier: NCT03908203    
Other Study ID Numbers: NS02-02
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: September 11, 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
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases