Clinical Trials Directory

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

TypeNameDescription
PROCEDUREPEEK interspinous spacerTo 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.