Safety Study of ARO Spinal System as an Adjunct to Lumbar Decompression
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by ARO Medical.
Recruitment status was: Active, not recruiting
Information provided by (Responsible Party):
First received: October 23, 2013
Last updated: January 13, 2015
Last verified: January 2015
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.
Lumbar Disc Prolapse With Radiculopathy
Device: ARO Spinal System
Early Phase 1
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Safety profile compared to historical controls and improvement in leg and back pain [ Time Frame: One year ]
Secondary Outcome Measures:
- 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 ]
Other Outcome Measures:
- The percentage of patients very or somewhat satisfied with their symptoms is greater than historical control [ Time Frame: 1 year ]
- There is an increase in the percentage of patients with evidence of annular healing in comparison to historical control [ Time Frame: 1 year ]
- There is a decrease in the percentage of patients with evidence of facet degenerative changes in comparison to historical control [ Time Frame: 1 year ]
- There is a reduction in the percentage of patients with degenerative changes in the disc in comparison to historical control [ Time Frame: 1 year ]
- There is a reduction in the axial rotation motion on the operative level compared to pre-operative motion [ Time Frame: 1 year ]
- Surgery with the device has no neurological impact [ Time Frame: 1 year ]
- The rate of reherniation is less than in historical control [ Time Frame: 1 year ]
- The percent of patients disabled at one year is less than in historical controls [ Time Frame: 1 year ]
- The device has a neutral cost/benefit profile in comparison to historical controls to permit further clinical study [ Time Frame: 1 year ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2015 (Final data collection date for primary outcome measure)
Experimental: ARO Spinal System
ARO Spinal System
Device: ARO Spinal System
The device provides an internal axial rotation orthosis (ARO) for patients being surgically treated for herniated nucleus pulposus (HNP).
|Ages Eligible for Study:
||18 Years to 55 Years (Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
Radicular pain and evidence of nerve-root irritation lasting 6 weeks or more as evidenced by both:
- Radicular pain - below the knee,
- 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.
- 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.
- Previous lumbar surgery
- Cauda equine syndrome
- Scoliosis greater than 15 degrees
- Segmental instability (> 10 degrees angular motion or >4mm translation)
- Vertebral fractures
- Spinal Infections
- Spinal tumors
- Inflammatory spondyloarthropathy
- Pregnancy or the intent to become pregnant in the following year
- Comorbid conditions contraindicating surgery
- Multiple herniations
- Known allergy to titanium, aluminum or vanadium
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01970514
|Aarhus University Hospital
|Aarhus, Denmark, DK-8000 |
||Cody Bunger, MD, DrMedSc
||Aarhus University Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 23, 2013
||January 13, 2015
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 23, 2017
Intervertebral Disc Displacement
Pathological Conditions, Anatomical
Peripheral Nervous System Diseases
Nervous System Diseases