Clinical trial NCT01970514: Safety Study of ARO Spinal System as an Adjunct to Lumbar Decompression
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Lumbar Disc Prolapse With Radiculopathy
Lead sponsor: ARO Medical
Sponsor class: INDUSTRY
First posted: 2013-10-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Safety profile compared to historical controls and improvement in leg and back pain
timeFrame: One year
Secondary outcomes:
measure: Oswestry Disability Index (ODI) improvement is superior to historical control
timeFrame: 1 year
measure: VAS back pain improvement is superior to historical control
timeFrame: 1 year
measure: VAS leg pain improvement is superior to historical control,
timeFrame: 1 year
Other outcomes:
measure: The percentage of patients very or somewhat satisfied with their symptoms is greater than historical control
timeFrame: 1 year
measure: There is an increase in the percentage of patients with evidence of annular healing in comparison to historical control
timeFrame: 1 year
measure: There is a decrease in the percentage of patients with evidence of facet degenerative changes in comparison to historical control
timeFrame: 1 year
measure: There is a reduction in the percentage of patients with degenerative changes in the disc in comparison to historical control
timeFrame: 1 year
measure: There is a reduction in the axial rotation motion on the operative level compared to pre-operative motion
timeFrame: 1 year
measure: Surgery with the device has no neurological impact
timeFrame: 1 year
measure: The rate of reherniation is less than in historical control
timeFrame: 1 year
measure: The percent of patients disabled at one year is less than in historical controls
timeFrame: 1 year
measure: The device has a neutral cost/benefit profile in comparison to historical controls to permit further clinical study
timeFrame: 1 year
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Cody Bunger, MD, DrMedSc
role: PRINCIPAL_INVESTIGATOR
References: