Minimally Invasive Surgery Versus Traditional Open Surgery In The Treatment Of Single Level Lumbar Stenosis

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

Status

Withdrawn

Conditions

Lumbar Spinal Stenosis

Intervertebral Disc Degeneration

Treatments

Device: Lumbar fusion

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04408846

NS02-01

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness of minimally invasive surgical technique over the traditional open surgical procedure in patients with degenerative lumbar stenosis

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 to 75 years;
Patient has single level degenerative lumbar spinal stenosis and an indication for a single level instrumented lumbar fusion for the treatment;
Symptoms persisting for at least three months prior to surgery;
Given written Informed Consent;
Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.

Exclusion criteria

Prior lumbar spinal fusion at any level;
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;
Any condition that cannot be treated with mini-invasive unilateral decompression and fusion;
History or presence of any other major neurological disease or condition that may interfere with the study assessments (e.g. significant peripheral neuropathy, multiply sclerosis);
Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).