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Status unknownNCT01970514Updated Jan 14, 2015

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

An Early Phase 1 interventional study of ARO Spinal System in Lumbar Disc Prolapse With Radiculopathy, sponsored by ARO Medical. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-01-14.

Sponsored by ARO Medical · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the detailed description

Not provided

02

Conditions studied

  • Lumbar Disc Prolapse With Radiculopathy
03

In context

Intervertebral Disc Displacement

477 studies on the registry are indexed under Intervertebral Disc Displacement; 103 are open to participants now.

This study's planned enrollment of 20 is below the median of 63 across 344 interventional studies indexed under Intervertebral Disc Displacement.

Browse Intervertebral Disc Displacement studies →

Lead sponsor

This is the only study on the registry with ARO Medical as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
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

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    ARO Spinal System

    ARO Spinal System

    Device: ARO Spinal System

Interventions

  • DeviceARO Spinal System

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

06

What researchers measure

Primary outcomes

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

    Time frame: One year

Secondary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Aarhus University Hospital
    Aarhus, DK-8000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01970514
Lead sponsor
ARO Medical
Responsible party
Sponsor
First posted
Oct 28, 2013
Start date
Apr 2012
Primary completion
Jul 2015 (estimated)
Completion
Jul 2015 (estimated)
Last update
Jan 14, 2015

Study contacts

Cody Bunger, MD, DrMedSc
principal investigator · Aarhus University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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