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

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

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Intervertebral Disc Degeneration Spinal Fusion

Interventions

Minimally invasive one-level lumbar deformity correctionPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Novosibirsk, Russia

Outcomes

Primary Outcomes

Angle change at lumbar spine segment

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 Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 12 months

Range of Motion

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

Data from ClinicalTrials.gov

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