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

Primary Purpose

Lumbar Disc Prolapse With Radiculopathy

Status

Unknown status

Phase

Early Phase 1

Locations

Denmark

Study Type

Interventional

Intervention

ARO Spinal System

About this trial

This is an interventional treatment trial for Lumbar Disc Prolapse With Radiculopathy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
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,
18 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.

Exclusion Criteria:

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.

Sites / Locations

Aarhus University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ARO Spinal System

Arm Description

ARO Spinal System

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Oswestry Disability Index (ODI) improvement is superior to historical control

VAS back pain improvement is superior to historical control

VAS leg pain improvement is superior to historical control,

Full Information

NCT ID

NCT01970514

First Posted

October 23, 2013

Last Updated

January 13, 2015

Sponsor

ARO Medical

1. Study Identification

Unique Protocol Identification Number

NCT01970514

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Unknown status

Study Start Date

April 2012 (undefined)

Primary Completion Date

July 2015 (Anticipated)

Study Completion Date

July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ARO Medical

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lumbar Disc Prolapse With Radiculopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ARO Spinal System

Arm Type

Experimental

Arm Description

ARO Spinal System

Intervention Type

Device

Intervention Name(s)

ARO Spinal System

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

One year

Secondary Outcome Measure Information:

Title

Oswestry Disability Index (ODI) improvement is superior to historical control

Time Frame

1 year

Title

VAS back pain improvement is superior to historical control

Time Frame

1 year

Title

VAS leg pain improvement is superior to historical control,

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

The percentage of patients very or somewhat satisfied with their symptoms is greater than historical control

Time Frame

1 year

Title

There is an increase in the percentage of patients with evidence of annular healing in comparison to historical control

Time Frame

1 year

Title

There is a decrease in the percentage of patients with evidence of facet degenerative changes in comparison to historical control

Time Frame

1 year

Title

There is a reduction in the percentage of patients with degenerative changes in the disc in comparison to historical control

Time Frame

1 year

Title

There is a reduction in the axial rotation motion on the operative level compared to pre-operative motion

Time Frame

1 year

Title

Surgery with the device has no neurological impact

Time Frame

1 year

Title

The rate of reherniation is less than in historical control

Time Frame

1 year

Title

The percent of patients disabled at one year is less than in historical controls

Time Frame

1 year

Title

The device has a neutral cost/benefit profile in comparison to historical controls to permit further clinical study

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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, 18 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cody Bunger, MD, DrMedSc

Organizational Affiliation

Aarhus University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aarhus University Hospital

City

Aarhus

ZIP/Postal Code

DK-8000

Country

Denmark

12. IPD Sharing Statement

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

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