PEEK Versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration (WallisvsDiam)

University Hospital of Patras

Status: Completed

Conditions: Adjacent Segment Degeneration

Treatments: Procedure: PEEK interspinous spacer

Study type: Interventional

Funder types: Other

Identifiers

NCT03477955

WALLIS2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 49 to 71 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

55 participants in 3 patient groups

Peek Group

Active Comparator group

Description:

Patients that received PEEK interspinous spacer

Treatment:

Procedure: PEEK interspinous spacer

Silicon Group

Active Comparator group

Description:

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

Treatment:

Procedure: PEEK interspinous spacer

Control Group

Active Comparator group

Description:

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

Treatment:

Procedure: PEEK interspinous spacer