Safety Study of ARO Spinal System as an Adjunct to Lumbar Decompression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01970514
Recruitment Status : Unknown
Verified January 2015 by ARO Medical.
Recruitment status was:  Active, not recruiting
First Posted : October 28, 2013
Last Update Posted : January 14, 2015
Information provided by (Responsible Party):
ARO Medical

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.

Condition or disease Intervention/treatment Phase
Lumbar Disc Prolapse With Radiculopathy Device: ARO Spinal System Early Phase 1

Detailed Description:
Not provided

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2012
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herniated Disk
U.S. FDA Resources

Arm Intervention/treatment
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).

Primary Outcome Measures :
  1. Safety profile compared to historical controls and improvement in leg and back pain [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Oswestry Disability Index (ODI) improvement is superior to historical control [ Time Frame: 1 year ]
  2. VAS back pain improvement is superior to historical control [ Time Frame: 1 year ]
  3. VAS leg pain improvement is superior to historical control, [ Time Frame: 1 year ]

Other Outcome Measures:
  1. The percentage of patients very or somewhat satisfied with their symptoms is greater than historical control [ Time Frame: 1 year ]
  2. There is an increase in the percentage of patients with evidence of annular healing in comparison to historical control [ Time Frame: 1 year ]
  3. There is a decrease in the percentage of patients with evidence of facet degenerative changes in comparison to historical control [ Time Frame: 1 year ]
  4. There is a reduction in the percentage of patients with degenerative changes in the disc in comparison to historical control [ Time Frame: 1 year ]
  5. There is a reduction in the axial rotation motion on the operative level compared to pre-operative motion [ Time Frame: 1 year ]
  6. Surgery with the device has no neurological impact [ Time Frame: 1 year ]
  7. The rate of reherniation is less than in historical control [ Time Frame: 1 year ]
  8. The percent of patients disabled at one year is less than in historical controls [ Time Frame: 1 year ]
  9. The device has a neutral cost/benefit profile in comparison to historical controls to permit further clinical study [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01970514

Aarhus University Hospital
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
ARO Medical
Principal Investigator: Cody Bunger, MD, DrMedSc Aarhus University Hospital

Responsible Party: ARO Medical Identifier: NCT01970514     History of Changes
Other Study ID Numbers: ARO-01
First Posted: October 28, 2013    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Intervertebral Disc Displacement
Pathological Conditions, Anatomical
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases