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

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.

Study Overview

• Status: Withdrawn
• Conditions: Intervertebral Disc Degeneration; Spinal Fusion
• Intervention / Treatment: Procedure: Minimally invasive one-level lumbar deformity correction

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630091
    • Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3, 6, 12 months
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).	3, 6, 12 months
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).	3, 6, 12 months
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.	12 months
Range of Motion	To observe the disc mobility at the treated level	At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months
Sagittal balance parameters	To observe sagittal balance as compared to baseline	At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months
Disc height	To observe disc height at the treated level as compared to baseline	At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months
Blood loss	Blood loss	Day of surgery
Surgery duration	Surgery duration	Day of surgery

Collaborators and Investigators

• Sponsor: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
• Collaborators: DePuy International
• Investigators: Principal Investigator: Aleksandr V Krutko, PhD, MD, Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2020
• Primary Completion (ANTICIPATED): April 1, 2021
• Study Completion (ANTICIPATED): April 1, 2022

Study Registration Dates

• First Submitted: April 6, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (ACTUAL): April 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: NS02-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No