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

Mohammad ARAB MOTLAGH

Status: Completed

Conditions: Vertebral Fusion

Treatments: Device: PEEK; Device: TiPEEK

Study type: Interventional

Funder types: Other

Identifiers

NCT03063008

TiPEEK Cage

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Lumbar fusion with PEEK cage

Other group

Description:

Control arm

Treatment:

Device: PEEK

Lumbar fusion with TiPEEK cage

Other group

Description:

Study arm

Treatment:

Device: TiPEEK