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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by ARO Medical
Sponsor:
Information provided by (Responsible Party):
ARO Medical
ClinicalTrials.gov Identifier:
NCT01970514
First received: October 23, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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 Intervention Phase
Lumbar Disc Prolapse With Radiculopathy
Device: ARO Spinal System
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ARO Medical:

Primary Outcome Measures:
  • Safety profile compared to historical controls and improvement in leg and back pain [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Oswestry Disability Index (ODI) improvement is superior to historical control [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • VAS back pain improvement is superior to historical control [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • VAS leg pain improvement is superior to historical control, [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

Detailed Description:

Not provided

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01970514

Contacts
Contact: Bruce Robie, PhD 201-757-1581 brobie@AROmedical.com

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

No publications provided

Responsible Party: ARO Medical
ClinicalTrials.gov Identifier: NCT01970514     History of Changes
Other Study ID Numbers: ARO-01
Study First Received: October 23, 2013
Last Updated: October 23, 2013
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Intervertebral Disk Displacement
Prolapse
Radiculopathy
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 24, 2014