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.
Not provided
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The device provides an internal axial rotation orthosis (ARO) for patients being surgically treated for herniated nucleus pulposus (HNP).
Aarhus University Hospital
Aarhus, Denmark
Safety profile compared to historical controls and improvement in leg and back pain
Time frame: One year
Oswestry Disability Index (ODI) improvement is superior to historical control
Time frame: 1 year
VAS back pain improvement is superior to historical control
Time frame: 1 year
VAS leg pain improvement is superior to historical control,
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.