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

Randomized Evaluation of Bone Ingrowth After Intervertebral Body Fusion With Either MectaLIF® PEEK or MectaLIF® TiPEEK Oblique

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03063008

Enrollment

Registered

2017-02-24

Start date

2012-01-16

Completion date

2013-12-01

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vertebral Fusion

Keywords

Lumbar spine; Fusion; Titanium; PEEK

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.

Interventions

DEVICEPEEK

Procedure/Surgery: TLIF fusion with common PEEK cages.

DEVICETiPEEK

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Fusion result	12 months	Fusion rate after instrumented transforaminal lumbar fusion with TiPEEK or common PEEK

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026