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

Vertebral Fusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03063008
• Other study ID #: TiPEEK Cage
• Status: Completed
• Phase: N/A
• First received: February 16, 2017
• Last updated: February 23, 2017
• Start date: January 16, 2012
• Est. completion date: December 1, 2013

Study information

• Verified date: February 2017
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 1, 2013
• Est. primary completion date: September 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vertebral Fusion

Intervention

Device:
• PEEK
Procedure/Surgery: TLIF fusion with common PEEK cages.
• TiPEEK
Procedure/Surgery: TLIF fusion with titanium coated PEEK cages.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mohammad ARAB MOTLAGH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fusion result	Fusion rate after instrumented transforaminal lumbar fusion with TiPEEK or common PEEK	12 months