Transforaminal Lumbar Interbody Fusion in PEEK Oblique Cages With and Without Titanium Coating

Mohammad ARAB MOTLAGH40 enrolled

Overview

Clinical outcome with regard to oswestry disability index and lumbar fusion rate after implantation of titanium coated PEEK cage and common PEEK cage

Cages made of polyetheretherketone (PEEK) and titanium materials reliably produce successful fusion rates and good clinical outcomes. However, there is a paucity of studies that have assessed the optimal material of cage systems. The primary objective of this study was to compare the Oswestry Disability Index (ODI) after instrumented transforaminal lumbar interbody fusion (TLIF) using either titanium-coated polyetheretherketone (TiPEEK) or common PEEK cages. Secondary objectives were to assess differences in fusion rates and differences in pain and in quality of life between these groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Vertebral Fusion

Interventions

PEEKDEVICE

Procedure/Surgery: TLIF fusion with common PEEK cages.

TiPEEKDEVICE

Procedure/Surgery: TLIF fusion with titanium coated PEEK cages.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Persistence of * low back pain, * sciatica and * spinal claudication after conservative treatment attributed to L3 to L5 lumbar segments. Exclusion Criteria: * previous lumbar spinal surgery * body mass index \>35 kg/m²

Outcomes

Primary Outcomes

Clinical outcome assessed by Oswestry Disability Index (ODI) after instrumented transforaminal lumbar fusion with TiPEEK or common PEEK

Oswestry Disability Index (ODI) after instrumented transforaminal lumbar fusion with TiPEEK or common PEEK

Time frame: 12 months

Secondary Outcomes

Fusion result

Fusion rate after instrumented transforaminal lumbar fusion with TiPEEK or common PEEK

Time frame: 12 months

Data from ClinicalTrials.gov

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