Transforaminal Lumbar Interbody Fusion in PEEK Oblique Ca... | NCT03063008

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

NCT03063008

Sponsor

Mohammad ARAB MOTLAGH

Status

Completed

Last Update Posted

Feb 24, 2017Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Vertebral Fusion

Interventions

PEEK
TiPEEK

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 16, 2012Actual

Primary Completion Date

Sep 1, 2013Actual

Completion Date

Dec 1, 2013Actual

First Submitted Date

Feb 16, 2017

First Submission Date that Met QC Criteria

Feb 23, 2017

First Posted Date

Feb 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2017

Last Update Posted Date

Feb 24, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lumbar fusion with PEEK cage	Other	Control arm	Device: PEEK
Lumbar fusion with TiPEEK cage	Other	Study arm	Device: TiPEEK

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PEEK	Device	Procedure/Surgery: TLIF fusion with common PEEK cages.	Lumbar fusion with PEEK cage

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohammad Arabmotlagh, MD, PhD	Department of Orthopedic Surgery, University Hospital Frankfurt	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided