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

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

Sponsors

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

Collaborator: Medtronic

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

Overall Status Not yet recruiting
Start Date December 1, 2020
Completion Date December 1, 2023
Primary Completion Date December 1, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from baseline in Oswestry Disability Index (ODI) 3 months
Secondary Outcome
Measure Time Frame
Change from baseline in Oswestry Disability Index (ODI) Through 2 years
Change from baseline in Numeric Pain Rating Score (NPRS) Through 2 years
Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D) Through 2 years
Change from baseline in Douleur Neuropathique 4 (DN4) Through 2 years
Change from baseline in The Health Transition Item from SF-36 (HTI Item) Through 2 years
Change from baseline in Clinical Global Impression Of Change (CGIC) scale Through 2 years
Fusion rate success 12 months and 24 months post op
Cost-effectiveness 14th day of hospital stay
Adverse Events Through 2 years
Enrollment 96
Condition
Intervention

Intervention Type: Device

Intervention Name: Lumbar fusion

Description: Patients will receive a single level instrumented fusion using a minimally invasive or open traditional surgical procedure with a posterior fixation. For the use of a posterior fixation system, the CD Horizon® Spinal System, is mandatory in this study and will be either minimally invasive or open.

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).

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Contact

Last Name: Aleksandr V Krutko, PhD, MD

Phone: +7(383)3733201

Phone Ext.: 1425

Email: [email protected]

Location
Facility: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Location Countries

Russian Federation

Verification Date

May 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Minimally invasive lumbar fusion

Type: Other

Label: Open posterior lumbar fusion

Type: Other

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov