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

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

Status

Withdrawn

Conditions

Intervertebral Disc Degeneration

Spinal Fusion

Treatments

Procedure: Minimally invasive one-level lumbar deformity correction

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03908203

NS02-02

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.