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

NCT ID: NCT01970514

Last Updated: 2015-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-07-31

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

Conditions

Lumbar Disc Prolapse With Radiculopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARO Spinal System

ARO Spinal System

Group Type: EXPERIMENTAL

ARO Spinal System

Intervention Type: DEVICE

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

Interventions

ARO Spinal System

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ARO Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cody Bunger, MD, DrMedSc

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

ARO-01

Identifier Type: -

Identifier Source: org_study_id