Clinical trial NCT04408846: Minimally Invasive Surgery Versus Traditional Open Surgery In The Treatment Of Single Level Lumbar Stenosis
Official title: An Open-Label Randomized Controlled Study of the Efficacy of Surgical Treatment in Patients With Single Level Lumbar Spinal Stenosis Using Minimally Invasive Surgery and Traditional Open Surgical Procedure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Intervertebral Disc Degeneration
Lumbar Spinal Stenosis
Lead sponsor: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Sponsor class: OTHER_GOV
Collaborators: name: Medtronic
First posted: 2020-05-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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


Eligibility criteria: 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).

Primary outcomes:
measure: Change from baseline in Oswestry Disability Index (ODI)
timeFrame: 3 months
Secondary outcomes:
measure: Change from baseline in Oswestry Disability Index (ODI)
timeFrame: Through 2 years
measure: Change from baseline in Numeric Pain Rating Score (NPRS)
timeFrame: Through 2 years
measure: Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D)
timeFrame: Through 2 years
measure: Change from baseline in Douleur Neuropathique 4 (DN4)
timeFrame: Through 2 years
measure: Change from baseline in The Health Transition Item from SF-36 (HTI Item)
timeFrame: Through 2 years
measure: Change from baseline in Clinical Global Impression Of Change (CGIC) scale
timeFrame: Through 2 years
measure: Fusion rate success
timeFrame: 12 months and 24 months post op
measure: Cost-effectiveness
timeFrame: 14th day of hospital stay
measure: Adverse Events
timeFrame: Through 2 years
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Study officials:
References: