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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Intervertebral Disc Degeneration, Lumbar Spinal Stenosis

Intervention / Treatment
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* Device: Lumbar fusion


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Minimally invasive lumbar fusion<br> | Device: Lumbar fusion<br>* 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.<br>|
| Other: Open posterior lumbar fusion<br> | Device: Lumbar fusion<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Change from baseline in Clinical Global Impression Of Change (CGIC) scale | To observe the change of CGIC through follow-up terms | Through 2 years | 
| Fusion rate success | Interbody fusion rate on CT based on Tan grades | 12 months and 24 months post op | 
| 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 | 
| Adverse Events | Document Adverse Events (incl. adverse events related to device) occurrence throughout the study | Through 2 years |