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

NCT ID: NCT03908203

Last Updated: 2020-09-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-04-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Group Type: OTHER

Minimally invasive one-level lumbar deformity correction

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy International

INDUSTRY

Sponsor Role: collaborator

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aleksandr V Krutko, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Novosibirsk, , Russia

Countries

Russia

Other Identifiers

NS02-02

Identifier Type: -

Identifier Source: org_study_id