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

Not Applicable

Completed

• Conditions: Vertebral Fusion
• Interventions: Device: PEEK; Device: TiPEEK

• Registration Number: NCT03063008
• Lead Sponsor: Mohammad ARAB MOTLAGH

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2012-01-16
• Primary Completion: 2013-09-01
• Study Completion: 2013-12-01
• Status Verified: 2017-02
• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-23
• Last Update Submitted: 2017-02-23
• Study First Posted: 2017-02-24
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumbar fusion with PEEK cage	PEEK	Control arm
Lumbar fusion with TiPEEK cage	TiPEEK	Study arm

Primary Outcome Measures

Name	Time	Method
Clinical outcome assessed by Oswestry Disability Index (ODI) after instrumented transforaminal lumbar fusion with TiPEEK or common PEEK	12 months	Oswestry Disability Index (ODI) after instrumented transforaminal lumbar fusion with TiPEEK or common PEEK

Secondary Outcome Measures

Name	Time	Method
Fusion result	12 months	Fusion rate after instrumented transforaminal lumbar fusion with TiPEEK or common PEEK