Trials / Unknown
UnknownNCT01970514
Safety Study of ARO Spinal System as an Adjunct to Lumbar Decompression
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
- Status
- Unknown
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- ARO Medical · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ARO Spinal System | The device provides an internal axial rotation orthosis (ARO) for patients being surgically treated for herniated nucleus pulposus (HNP). |
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2015-07-01
- Completion
- 2015-07-01
- First posted
- 2013-10-28
- Last updated
- 2015-01-14
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT01970514. Inclusion in this directory is not an endorsement.