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

A

ARO Medical

Status and phase

Unknown
Early Phase 1

Conditions

Lumbar Disc Prolapse With Radiculopathy

Treatments

Device: ARO Spinal System

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full description

Not provided

Enrollment

20 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

ARO Spinal System
Experimental group
Description:
ARO Spinal System
Treatment:
Device: ARO Spinal System

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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