"Randomized Evaluation of Bone Ingrowth After Intervertebral Body Fusion With Either MectaLIF® PEEK or MectaLIF® TiPEEK Oblique"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Primary Endpoint
- Clinical outcome assessed by Oswestry Disability Index (ODI) after instrumented transforaminal lumbar fusion with TiPEEK or common PEEK
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Lumbar fusion with PEEK cage
Control arm
Intervention: PEEK (Device)
Lumbar fusion with TiPEEK cage
Study arm
Intervention: TiPEEK (Device)
Outcomes
Primary Outcomes
Clinical outcome assessed by Oswestry Disability Index (ODI) after instrumented transforaminal lumbar fusion with TiPEEK or common PEEK
Time Frame: 12 months
Oswestry Disability Index (ODI) after instrumented transforaminal lumbar fusion with TiPEEK or common PEEK
Secondary Outcomes
- Fusion result(12 months)
Investigators
Mohammad ARAB MOTLAGH
MD, PhD
Johann Wolfgang Goethe University Hospital