PEEK Versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration Following Decompression and Short-Segment Instrumentation for Degenerative Lumbar Spinal Stenosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 55
- Primary Endpoint
- Quality of Life
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 49 Years to 71 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control Group
Patients that did not receive PEEK interspinous spacer nor Silicon interspinous spacer
Intervention: PEEK interspinous spacer (Procedure)
Peek Group
Patients that received PEEK interspinous spacer
Intervention: PEEK interspinous spacer (Procedure)
Silicon Group
Patients that received Silicon interspinous spacer and did not receive PEEK interspinous spacer
Intervention: PEEK interspinous spacer (Procedure)
Outcomes
Primary Outcomes
Quality of Life
Time Frame: Three years
Oswestry Disability Index scale (0-100)
Secondary Outcomes
- Disc heights(Three years)
- Sacral Slope(Three years)
- Pain(Three years)
Investigators
Vasileios Syrimpeis
Orthopaedic Surgeon
University Hospital of Patras