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OpenTrials
Completed

NCT Number: NCT03063008

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

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

Completed

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Key information

Conditions

Vertebral Fusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEEK

Device

Procedure/Surgery:

TLIF fusion with common PEEK cages.

TiPEEK

Device

Procedure/Surgery:

TLIF fusion with titanium coated PEEK cages.

Primary outcomes

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

    Time frame: 12 months

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

Secondary outcomes

  1. Fusion result

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Mohammad ARAB MOTLAGH

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 24, 2017
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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