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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03477955

Acronym

WallisvsDiam

Enrollment

Registered

2018-03-27

Start date

2006-04-30

Completion date

2009-11-30

Last updated

2018-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjacent Segment Degeneration

Keywords

spinopelvic alignment, short lumbosacral instrumentation, PEEK, silicon spacer

Brief 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.

Interventions

PROCEDUREPEEK interspinous spacer

To study the Adjacent Segment Degeneration incidence in the supradjacent segment following short lumbar fusion between PEEK and Silicon Interspinous spacers.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

49 Years to 71 Years

Healthy volunteers

Inclusion criteria

Preoperative MRI with degeneration grades\<III at the 1st supradjacent lumbar segment.

Exclusion criteria

* Body mass index≥40kg/m\*m * Severe osteoporosis * Lumbar fracture * Preoperative SVA\>4cm * Spondylolisthesis grades\>II or spondylolytic lesion and acquired spinous process insufficiency in the supradjacent segment cephalad to instrumentation

Design outcomes

Primary

Measure	Time frame	Description
Quality of Life	Three years	Oswestry Disability Index scale (0-100)

Secondary

Measure	Time frame	Description
Disc heights	Three years	Measured in cm
Sacral Slope	Three years	Measured in degrees
Pain	Three years	Visual Analog Scale (0-10)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026