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

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

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.

Study Overview

• Status: Unknown
• Conditions: Lumbar Disc Prolapse With Radiculopathy
• Intervention / Treatment: Device: ARO Spinal System

Detailed Description

Not provided

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, Dk-8000
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety profile compared to historical controls and improvement in leg and back pain	One year

Secondary Outcome Measures

Outcome Measure	Time Frame
Oswestry Disability Index (ODI) improvement is superior to historical control	1 year
VAS back pain improvement is superior to historical control	1 year
VAS leg pain improvement is superior to historical control,	1 year

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: ARO Medical
• Investigators: Principal Investigator: Cody Bunger, MD, DrMedSc, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: October 23, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (Estimate): October 28, 2013

Study Record Updates

• Last Update Posted (Estimate): January 14, 2015
• Last Update Submitted That Met QC Criteria: January 13, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Prolapse; Radiculopathy
• Other Study ID Numbers: ARO-01