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

NCT01970514 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-01-14

No results posted yet for this study

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.

Conditions

  • Lumbar Disc Prolapse With Radiculopathy

Interventions

DEVICE

ARO Spinal System

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

Sponsors & Collaborators

  • ARO Medical

    lead INDUSTRY

Principal Investigators

  • Cody Bunger, MD, DrMedSc · Aarhus University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01970514 on ClinicalTrials.gov