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

NCT03908203 | Withdrawn DMC

• 1 other identifier: NS02-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Intervertebral Disc Degeneration; Spinal Fusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Improvement of Visual analog scale (VAS) back pain intensity

  3, 6, 12 months

• Improvement of Visual analog scale (VAS) leg pain intensity

  3, 6, 12 months

• Improvement of Oswestry Disability Index (ODI)

  3, 6, 12 months

• Fusion rate success

  12 months

• Range of Motion

  At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months

Study Arms (1)

Treatment Arm

OTHER

Procedure: Minimally invasive one-level lumbar deformity correction

Interventions

Minimally invasive one-level lumbar deformity correction PROCEDURE

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.

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan: lead
• DePuy International: collaborator

Study Sites (1)

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

Novosibirsk, 630091, Russia

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Aleksandr V Krutko, PhD, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2019
• First Posted: April 9, 2019
• Study Start: October 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2022
• Last Updated: September 11, 2020

Record last verified: 2020-02

Locations

RU (1)