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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.
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Inclusion criteria
Radicular pain and evidence of nerve-root irritation lasting 6 weeks or more as evidenced by both:
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
Primary purpose
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Interventional model
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20 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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