PEEK Versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration
WallisvsDiam
1 other identifier
interventional
55
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2006
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 3, 2018
CompletedFirst Posted
Study publicly available on registry
March 27, 2018
CompletedApril 10, 2018
April 1, 2018
Same day
March 3, 2018
April 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Life
Oswestry Disability Index scale (0-100)
Three years
Secondary Outcomes (3)
Disc heights
Three years
Sacral Slope
Three years
Pain
Three years
Study Arms (3)
Peek Group
ACTIVE COMPARATORPatients that received PEEK interspinous spacer
Silicon Group
ACTIVE COMPARATORPatients that received Silicon interspinous spacer and did not receive PEEK interspinous spacer
Control Group
ACTIVE COMPARATORPatients that did not receive PEEK interspinous spacer nor Silicon interspinous spacer
Interventions
To study the Adjacent Segment Degeneration incidence in the supradjacent segment following short lumbar fusion between PEEK and Silicon Interspinous spacers.
Eligibility Criteria
You may qualify if:
- Preoperative MRI with degeneration grades\<III at the 1st supradjacent lumbar segment.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Korovessis P, Syrimpeis V, Tsekouras V, Vardakastanis K, Fennema P. PEEK versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration following Decompression and Short-Segment Instrumentation for Degenerative Lumbar Spinal Stenosis. Adv Orthop. 2018 Aug 8;2018:1623647. doi: 10.1155/2018/1623647. eCollection 2018.
PMID: 30174959DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Panagiotis Korovessis, PhD
General Hospital of Patras
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Orthopaedic Surgeon
Study Record Dates
First Submitted
March 3, 2018
First Posted
March 27, 2018
Study Start
April 1, 2006
Primary Completion
April 1, 2006
Study Completion
November 1, 2009
Last Updated
April 10, 2018
Record last verified: 2018-04