Trials / Unknown
UnknownNCT01918943
Evaluation of Aspen Spinous Process Fixation System and PLIF Technique for the Treatment of Low Back Pain
Evaluation of Aspen Spinous Process Fixation System and PLIF Technique for the Treatment of Low Back Pain in the Presence of Lumbar Instability and Degenerative Disk Disease
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (estimated)
- Sponsor
- American British Cowdray Medical Center · Academic / Other
- Sex
- All
- Age
- 40 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Lumbar spinal fusion was introduced approximately 70 years ago and has evolved as a treatment option for symptomatic spinal instability, spinal stenosis, spondylolisthesis, and degenerative scoliosis. Many techniques evolved since then, from wiring, rods, pedicle screws, and recently inter-spinous fixation devices like the Aspen. Along its evolutionary trail, various methods for achieving circumferential fusion have arisen. Distinct from staged anterior/posterior fusion techniques, two methods of achieving an interbody fusion from a posterior approach have emerged: posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF). Recently, the lateral approach for interbody fusion (XLIF) has became a more common technique, requiring in some cases, complemental posterior fixation with pedicle screws, facet screws or interspinous fixation devices like the Aspen device. In this study, we address the clinical and radiological outcome of a novel technique using standard PLIF interbody fusion and insertion of the Aspen device via posterior lumbar approach.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PLIF and Aspen (spinous process fixation device) | Circunferential fusion with PLIF and postero-lateral fusion with the Aspen device |
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2013-08-08
- Last updated
- 2013-08-08
Locations
1 site across 1 country: Mexico
Source: ClinicalTrials.gov record NCT01918943. Inclusion in this directory is not an endorsement.