PEEK Versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration

Study Overview
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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.

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.

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

Conditions
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Adjacent Segment Degeneration

Intervention / Treatment
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* Procedure: PEEK interspinous spacer


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 49 Years
Maximum Age: 71 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peek Group<br>Patients that received PEEK interspinous spacer | Procedure: PEEK interspinous spacer<br>* To study the Adjacent Segment Degeneration incidence in the supradjacent segment following short lumbar fusion between PEEK and Silicon Interspinous spacers.<br>* Other names: Silicon interspinous spacer;|
| Active Comparator: Silicon Group<br>Patients that received Silicon interspinous spacer and did not receive PEEK interspinous spacer | Procedure: PEEK interspinous spacer<br>* To study the Adjacent Segment Degeneration incidence in the supradjacent segment following short lumbar fusion between PEEK and Silicon Interspinous spacers.<br>* Other names: Silicon interspinous spacer;|
| Active Comparator: Control Group<br>Patients that did not receive PEEK interspinous spacer nor Silicon interspinous spacer | Procedure: PEEK interspinous spacer<br>* To study the Adjacent Segment Degeneration incidence in the supradjacent segment following short lumbar fusion between PEEK and Silicon Interspinous spacers.<br>* Other names: Silicon interspinous spacer;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinopelvic alignment, short lumbosacral instrumentation, PEEK, silicon spacer