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

Lumbar Disc Prolapse With Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01970514
• Other study ID #: ARO-01
• Status: Active, not recruiting
• Phase: Phase 0
• First received: October 23, 2013
• Last updated: January 13, 2015
• Start date: April 2012
• Est. completion date: July 2015

Study information

• Verified date: January 2015
• Source: ARO Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Description:

Not provided

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Lumbar Disc Prolapse With Radiculopathy
• Prolapse
• Radiculopathy

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
ARO Medical

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The percentage of patients very or somewhat satisfied with their symptoms is greater than historical control		1 year	No
Other	There is an increase in the percentage of patients with evidence of annular healing in comparison to historical control		1 year	No
Other	There is a decrease in the percentage of patients with evidence of facet degenerative changes in comparison to historical control		1 year	No
Other	There is a reduction in the percentage of patients with degenerative changes in the disc in comparison to historical control		1 year	No
Other	There is a reduction in the axial rotation motion on the operative level compared to pre-operative motion		1 year	No
Other	Surgery with the device has no neurological impact		1 year	No
Other	The rate of reherniation is less than in historical control		1 year	No
Other	The percent of patients disabled at one year is less than in historical controls		1 year	No
Other	The device has a neutral cost/benefit profile in comparison to historical controls to permit further clinical study		1 year	No
Primary	Safety profile compared to historical controls and improvement in leg and back pain		One year	Yes
Secondary	Oswestry Disability Index (ODI) improvement is superior to historical control		1 year	No
Secondary	VAS back pain improvement is superior to historical control		1 year	No
Secondary	VAS leg pain improvement is superior to historical control,		1 year	No