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

Primary Purpose

Intervertebral Disc Degeneration, Spinal Fusion

Status
Withdrawn
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Minimally invasive one-level lumbar deformity correction
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 treatment trial for Intervertebral Disc Degeneration

Eligibility Criteria

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

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment Arm

Arm Description

Outcomes

Primary Outcome Measures

Angle change at lumbar spine segment
Angle between endplates at the treated level of lumbar spine

Secondary Outcome Measures

Improvement of Visual analog scale (VAS) back pain intensity
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).
Improvement of Visual analog scale (VAS) leg pain intensity
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).
Improvement of Oswestry Disability Index (ODI)
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).
Fusion rate success
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.
Range of Motion
To observe the disc mobility at the treated level
Sagittal balance parameters
To observe sagittal balance as compared to baseline
Disc height
To observe disc height at the treated level as compared to baseline
Blood loss
Blood loss
Surgery duration
Surgery duration

Full Information

First Posted
April 6, 2019
Last Updated
September 9, 2020
Sponsor
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Collaborators
DePuy International
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1. Study Identification

Unique Protocol Identification Number
NCT03908203
Brief Title
Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction
Official Title
Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
The Study will be conducted in another research center. The Sponsor has changed.
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
April 1, 2021 (Anticipated)
Study Completion Date
April 1, 2022 (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
DePuy International

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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive one-level lumbar deformity correction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Angle change at lumbar spine segment
Description
Angle between endplates at the treated level of lumbar spine
Time Frame
At 1 Day of hospital discharge or 14th day of hospital stay (depends on what event comes first)
Secondary Outcome Measure Information:
Title
Improvement of Visual analog scale (VAS) back pain intensity
Description
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).
Time Frame
3, 6, 12 months
Title
Improvement of Visual analog scale (VAS) leg pain intensity
Description
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).
Time Frame
3, 6, 12 months
Title
Improvement of Oswestry Disability Index (ODI)
Description
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).
Time Frame
3, 6, 12 months
Title
Fusion rate success
Description
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.
Time Frame
12 months
Title
Range of Motion
Description
To observe the disc mobility at the treated level
Time Frame
At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months
Title
Sagittal balance parameters
Description
To observe sagittal balance as compared to baseline
Time Frame
At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months
Title
Disc height
Description
To observe disc height at the treated level as compared to baseline
Time Frame
At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months
Title
Blood loss
Description
Blood loss
Time Frame
Day of surgery
Title
Surgery duration
Description
Surgery duration
Time Frame
Day of surgery

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: 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.
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
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

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

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