Safety Study of ARO Spinal System as an Adjunct to Lumbar Decompression

Study Overview
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Brief Summary
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To evaluate the clinical safety and effectiveness of the ARO Spinal System and to assess preliminary cost/benefit analysis in patients undergoing decompression surgery for symptomatic lumbar disc herniations. The general hypothesis is that the ARO significantly improves outcomes in patients undergoing decompression surgery for symptomatic lumbar disc herniations.

Detailed Description
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Not provided

Official Title
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Temporary Axial Rotation Stabilization for Lumbar Disc Prolapse Surgery With the ARO® Spinal System: A Non-randomized Prospective Analysis of Clinical Efficacy, Safety and Cost Effectiveness

Conditions
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Lumbar Disc Prolapse With Radiculopathy

Intervention / Treatment
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* Device: ARO Spinal System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Radicular pain and evidence of nerve-root irritation lasting 6 weeks or more as evidenced by both: Radicular pain - below the knee, Nerve root irritation i. positive nerve root tension sign - straight leg raise positive between 30 and 70 degrees, or ii. positive femoral tension sign, or iii. neurologic deficit - asymmetrical depressed reflex or decreased sensation in a dermatomal distribution or weakness in a myotomal distribution. Primary one-level posterolateral herniation in the lower lumbar spine (L4-L5 or L5-S1 only) as shown by magnetic resonance (MR) imaging (protrusion, extrusion or sequestered fragment) consistent with the clinical symptoms (both level and side). The investigator confirms that the patient is a surgical candidate for discectomy, The patient has been scheduled for their surgical procedure no more than two months from time of consent, 18 years to 55 years of age at time of consent, Willing to complete the study requirements and permit agency and sponsor authorized personnel to access medical records, Able to understand oral and written Danish. Exclusion Criteria: Previous lumbar surgery Cauda equine syndrome Scoliosis greater than 15 degrees Osteoporosis Segmental instability (> 10 degrees angular motion or >4mm translation) Vertebral fractures Spinal Infections Spinal tumors Inflammatory spondyloarthropathy Pregnancy or the intent to become pregnant in the following year Comorbid conditions contraindicating surgery Multiple herniations Known allergy to titanium, aluminum or vanadium Female patients of childbearing age, who are not willing to use adequate contraception specified as: intrauterine devices, hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release). It is accepted in certain cases to include subjects having a sterilized permanent partner or subjects using double barrier contraceptive methods which is a condom combined with a diaphragm.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARO Spinal System<br>ARO Spinal System | Device: ARO Spinal System<br>* The device provides an internal axial rotation orthosis (ARO) for patients being surgically treated for herniated nucleus pulposus (HNP).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile compared to historical controls and improvement in leg and back pain |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) improvement is superior to historical control |  | 1 year | 
| VAS back pain improvement is superior to historical control |  | 1 year | 
| VAS leg pain improvement is superior to historical control, |  | 1 year |