Lumbar Disc Prolapse With Radiculopathy
Conditions
Brief summary
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
Not provided
Interventions
DEVICEARO Spinal System
The device provides an internal axial rotation orthosis (ARO) for patients being surgically treated for herniated nucleus pulposus (HNP).
Sponsors
ARO Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Radicular pain and evidence of nerve-root irritation lasting 6 weeks or more as evidenced by both: 1. Radicular pain - below the knee, 2. 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. 2. 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). 3. The investigator confirms that the patient is a surgical candidate for discectomy, 4. The patient has been scheduled for their surgical procedure no more than two months from time of consent, 5. 18 years to 55 years of age at time of consent, 6. Willing to complete the study requirements and permit agency and sponsor authorized personnel to access medical records, 7. Able to understand oral and written Danish.
Exclusion criteria
1. Previous lumbar surgery 2. Cauda equine syndrome 3. Scoliosis greater than 15 degrees 4. Osteoporosis 5. Segmental instability (\> 10 degrees angular motion or \>4mm translation) 6. Vertebral fractures 7. Spinal Infections 8. Spinal tumors 9. Inflammatory spondyloarthropathy 10. Pregnancy or the intent to become pregnant in the following year 11. Comorbid conditions contraindicating surgery 12. Multiple herniations 13. Known allergy to titanium, aluminum or vanadium 14. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety profile compared to historical controls and improvement in leg and back pain | One year |
Secondary
| Measure | 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 |
Other
| Measure | Time frame |
|---|---|
| There is a reduction in the axial rotation motion on the operative level compared to pre-operative motion | 1 year |
| Surgery with the device has no neurological impact | 1 year |
| The percentage of patients very or somewhat satisfied with their symptoms is greater than historical control | 1 year |
| The percent of patients disabled at one year is less than in historical controls | 1 year |
| The device has a neutral cost/benefit profile in comparison to historical controls to permit further clinical study | 1 year |
| The rate of reherniation is less than in historical control | 1 year |
| There is an increase in the percentage of patients with evidence of annular healing in comparison to historical control | 1 year |
| There is a decrease in the percentage of patients with evidence of facet degenerative changes in comparison to historical control | 1 year |
| There is a reduction in the percentage of patients with degenerative changes in the disc in comparison to historical control | 1 year |
Countries
Denmark
Outcome results
None listed