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Completed

NCT Number: NCT03477955

PEEK Versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration

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.

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Key information

Conditions

Adjacent Segment Degeneration

Age range

49 year–71 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEEK interspinous spacer

Procedure

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

Other names: Silicon interspinous spacer

Primary outcomes

  1. Quality of Life

    Time frame: Three years

    Oswestry Disability Index scale (0-100)

Secondary outcomes

  1. Disc heights

    Time frame: Three years

    Measured in cm

  2. Sacral Slope

    Time frame: Three years

    Measured in degrees

  3. Pain

    Time frame: Three years

    Visual Analog Scale (0-10)

Sponsors and collaborators

Lead sponsor

University Hospital of Patras

Other

Collaborators

  • St. Andrew's General Hospital, Patras, Greece

Registry information

Official study title

PEEK Versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration Following Decompression and Short-Segment Instrumentation for Degenerative Lumbar Spinal Stenosis

Acronym: WallisvsDiam

Important dates

Study start
2006
Primary completion
2006
Study completion
2009
First posted
Mar 27, 2018
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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