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

Early Phase 1

• Conditions: Lumbar Disc Prolapse With Radiculopathy
• Interventions: Device: ARO Spinal System

• Registration Number: NCT01970514
• Lead Sponsor: 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.

Detailed Description

Not provided

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2013-10-23
• Study First Posted: 2013-10-28
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14
• Primary Completion: 2015-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARO Spinal System	ARO Spinal System	ARO Spinal System

Primary Outcome Measures

Name	Time	Method
Safety profile compared to historical controls and improvement in leg and back pain	One year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark