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

Lumbar Spinal Stenosis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04408846
• Other study ID #: NS02-01
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2020
• Source: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Constriction, Pathologic
• Intervertebral Disc Degeneration
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Device:
• Lumbar fusion
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.

Locations

Country	Name	City	State
Russian Federation	Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan	Novosibirsk

Sponsors (2)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Oswestry Disability Index (ODI)	To observe the change of ODI as compared to baseline through follow-up terms	3 months
Secondary	Change from baseline in Oswestry Disability Index (ODI)	To observe the change of ODI as compared to baseline through follow-up terms	Through 2 years
Secondary	Change from baseline in Numeric Pain Rating Score (NPRS)	To observe the change of NPRS as compared to baseline through follow-up terms	Through 2 years
Secondary	Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D)	To observe the change of EQ-5D as compared to baseline through follow-up terms	Through 2 years
Secondary	Change from baseline in Douleur Neuropathique 4 (DN4)	To observe the change of DN4 as compared to baseline through follow-up terms	Through 2 years
Secondary	Change from baseline in The Health Transition Item from SF-36 (HTI Item)	To observe the change of HTI Item through follow-up terms	Through 2 years
Secondary	Change from baseline in Clinical Global Impression Of Change (CGIC) scale	To observe the change of CGIC through follow-up terms	Through 2 years
Secondary	Fusion rate success	Interbody fusion rate on CT based on Tan grades	12 months and 24 months post op
Secondary	Cost-effectiveness	Total cost of surgical procedure (implanted system, the salary for surgery team) and the cost of patient's staying at the clinic before discharge.	14th day of hospital stay
Secondary	Adverse Events	Document Adverse Events (incl. adverse events related to device) occurrence throughout the study	Through 2 years