NCT03063008

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 24, 2017

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

1.6 years

First QC Date

February 16, 2017

Last Update Submit

February 23, 2017

Conditions

Vertebral Fusion

Keywords

Lumbar spine; Fusion; Titanium; PEEK

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Fusion result

    12 months

Study Arms (2)

Lumbar fusion with PEEK cage

OTHER

Control arm

Device: PEEK

Lumbar fusion with TiPEEK cage

OTHER

Study arm

Device: TiPEEK

Interventions

PEEKDEVICE

Procedure/Surgery: TLIF fusion with common PEEK cages.

Lumbar fusion with PEEK cage
TiPEEKDEVICE

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

Lumbar fusion with TiPEEK cage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persistence of
  • low back pain,
  • sciatica and
  • spinal claudication after conservative treatment attributed to L3 to L5 lumbar segments.

You may not qualify if:

  • previous lumbar spinal surgery
  • body mass index \>35 kg/m²

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Mohammad Arabmotlagh, MD, PhD

    Department of Orthopedic Surgery, University Hospital Frankfurt

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 16, 2017

First Posted

February 24, 2017

Study Start

January 16, 2012

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

February 24, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share