Overview

This trial is active, not recruiting.

Condition lumbar disc prolapse with radiculopathy
Treatment aro spinal system
Phase phase 0
Sponsor ARO Medical
Start date April 2012
End date July 2015
Trial size 20 participants
Trial identifier NCT01970514, ARO-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ARO Spinal System
aro spinal system
The device provides an internal axial rotation orthosis (ARO) for patients being surgically treated for herniated nucleus pulposus (HNP).

Primary Outcomes

Measure
Safety profile compared to historical controls and improvement in leg and back pain
time frame: One year

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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.

Additional Information

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
Principal investigator Cody Bunger, MD, DrMedSc
Description Not provided
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by ARO Medical.