Trials / Completed
CompletedNCT03477955
PEEK Versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration
PEEK Versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration Following Decompression and Short-Segment Instrumentation for Degenerative Lumbar Spinal Stenosis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- University Hospital of Patras · Academic / Other
- Sex
- All
- Age
- 49 Years – 71 Years
- Healthy volunteers
- Not accepted
Summary
A retrospective study that aims to report Adjacent Segment Degeneration (ASD) incidence and spinopelvic balance in short lumbosacral instrumentation for degenerative lumbar spinal stenosis. Although ASD is a common complication following lumbar fusion, the effect of an Interspinous Spacer (IS) in the supradjacent segment in short lumbosacral instrumented fusion and its interaction with spinopelvic balance has not been studied adequately.
Detailed description
Methods From 55 consecutive age-, diagnosis- and gender- matched patients aged 60±11 years, 17 (Group R) received PEEK IS; 18 (Group S) received Silicon IS and compared with 20 controls (Group C) without receiving any IS. The functional outcome was evaluated with VAS and ODI. Spinopelvic balance was evaluated using SVA, T12-S1 LL, SS, PT, PI and supradjacent segment disc heights. All spines were preoperatively balanced.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | PEEK interspinous spacer | To study the Adjacent Segment Degeneration incidence in the supradjacent segment following short lumbar fusion between PEEK and Silicon Interspinous spacers. |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2006-04-01
- Completion
- 2009-11-01
- First posted
- 2018-03-27
- Last updated
- 2018-04-10
Source: ClinicalTrials.gov record NCT03477955. Inclusion in this directory is not an endorsement.