PEEK Versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-11-30

Brief Summary

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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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Detailed Description

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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

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Adjacent Segment Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Peek Group

Patients that received PEEK interspinous spacer

Group Type ACTIVE_COMPARATOR

PEEK interspinous spacer

Intervention Type PROCEDURE

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

Silicon Group

Patients that received Silicon interspinous spacer and did not receive PEEK interspinous spacer

Group Type ACTIVE_COMPARATOR

PEEK interspinous spacer

Intervention Type PROCEDURE

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

Control Group

Patients that did not receive PEEK interspinous spacer nor Silicon interspinous spacer

Group Type ACTIVE_COMPARATOR

PEEK interspinous spacer

Intervention Type PROCEDURE

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

Interventions

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PEEK interspinous spacer

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

Intervention Type PROCEDURE

Other Intervention Names

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Silicon interspinous spacer

Eligibility Criteria

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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

Minimum Eligible Age

49 Years

Maximum Eligible Age

71 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No