PEEK Versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration (WallisvsDiam)

April 6, 2018 updated by: Vasileios Syrimpeis, University Hospital of Patras

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

49 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Peek Group
Patients that received PEEK interspinous spacer
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.
Other Names:
  • Silicon interspinous spacer
Active Comparator: Silicon Group
Patients that received Silicon interspinous spacer and did not receive PEEK interspinous spacer
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.
Other Names:
  • Silicon interspinous spacer
Active Comparator: Control Group
Patients that did not receive PEEK interspinous spacer nor Silicon interspinous spacer
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.
Other Names:
  • Silicon interspinous spacer

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Patras

Collaborators

St. Andrew's General Hospital, Patras, Greece

Investigators

  • Principal Investigator: Panagiotis Korovessis, PhD, General Hospital of Patras

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2006

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

March 3, 2018

First Submitted That Met QC Criteria

March 19, 2018

First Posted (Actual)

March 27, 2018

Study Record Updates

Last Update Posted (Actual)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 6, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WALLIS2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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