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

NCT ID: NCT03063008

Last Updated: 2017-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-16

Study Completion Date

2013-12-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Vertebral Fusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lumbar fusion with PEEK cage

Control arm

Group Type OTHER

PEEK

Intervention Type DEVICE

Procedure/Surgery:

TLIF fusion with common PEEK cages.

Lumbar fusion with TiPEEK cage

Study arm

Group Type OTHER

TiPEEK

Intervention Type DEVICE

Procedure/Surgery:

TLIF fusion with titanium coated PEEK cages.

Interventions

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PEEK

Procedure/Surgery:

TLIF fusion with common PEEK cages.

Intervention Type DEVICE

TiPEEK

Procedure/Surgery:

TLIF fusion with titanium coated PEEK cages.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mohammad ARAB MOTLAGH

OTHER

Sponsor Role lead

Responsible Party

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Mohammad ARAB MOTLAGH

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mohammad Arabmotlagh, MD, PhD

Role: STUDY_DIRECTOR

Department of Orthopedic Surgery, University Hospital Frankfurt

Other Identifiers

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TiPEEK Cage

Identifier Type: -

Identifier Source: org_study_id

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