PEEK Versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration

Adjacent Segment Degeneration Clinical Trial

— WallisvsDiam  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477955
• Other study ID #: WALLIS2018
• Status: Completed
• Phase: N/A
• First received: March 3, 2018
• Last updated: April 6, 2018
• Start date: April 2006
• Est. completion date: November 2009

Study information

• Verified date: April 2018
• Source: University Hospital of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 2009
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 49 Years to 71 Years

Eligibility

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

Related Conditions & MeSH terms

• Adjacent Segment Degeneration

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Patras	St. Andrew's General Hospital, Patras, Greece

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life	Oswestry Disability Index scale (0-100)	Three years
Secondary	Disc heights	Measured in cm	Three years
Secondary	Sacral Slope	Measured in degrees	Three years
Secondary	Pain	Visual Analog Scale (0-10)	Three years