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

NCT01970514 | Unknown Early Phase 1

• 1 other identifier: ARO-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Prolapse With Radiculopathy

Outcome Measures

Primary Outcomes (1)

• Safety profile compared to historical controls and improvement in leg and back pain

  One year

Secondary Outcomes (3)

• 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 Outcomes (9)

• 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

Study Arms (1)

ARO Spinal System

EXPERIMENTAL

ARO Spinal System

Device: ARO Spinal System

Interventions

ARO Spinal System DEVICE

The device provides an internal axial rotation orthosis (ARO) for patients being surgically treated for herniated nucleus pulposus (HNP).

ARO Spinal System

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• Previous lumbar surgery
• Cauda equine syndrome
• Scoliosis greater than 15 degrees
• Osteoporosis
• 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.

Sponsors & Collaborators

• ARO Medical: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, DK-8000, Denmark

Location

Study Officials

• Cody Bunger, MD, DrMedSc

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 28, 2013
• Study Start: April 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

DK (1)