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"

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

Study Overview

• Status: Completed
• Conditions: Vertebral Fusion
• Intervention / Treatment: Device: PEEK; Device: TiPEEK

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lumbar fusion with PEEK cage; Control arm	Device: PEEK; Procedure/Surgery: TLIF fusion with common PEEK cages.
Other: Lumbar fusion with TiPEEK cage; Study arm	Device: TiPEEK; Procedure/Surgery: TLIF fusion with titanium coated PEEK cages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mohammad ARAB MOTLAGH
• Investigators: Study Director: Mohammad Arabmotlagh, MD, PhD, Department of Orthopedic Surgery, University Hospital Frankfurt

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: February 23, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Lumbar spine; Fusion; Titanium; PEEK
• Other Study ID Numbers: TiPEEK Cage

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No