Trials / Completed
CompletedNCT03063008
Transforaminal Lumbar Interbody Fusion in PEEK Oblique Cages With and Without Titanium Coating
"Randomized Evaluation of Bone Ingrowth After Intervertebral Body Fusion With Either MectaLIF® PEEK or MectaLIF® TiPEEK Oblique"
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Mohammad ARAB MOTLAGH · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PEEK | Procedure/Surgery: TLIF fusion with common PEEK cages. |
| DEVICE | TiPEEK | Procedure/Surgery: TLIF fusion with titanium coated PEEK cages. |
Timeline
- Start date
- 2012-01-16
- Primary completion
- 2013-09-01
- Completion
- 2013-12-01
- First posted
- 2017-02-24
- Last updated
- 2017-02-24
Source: ClinicalTrials.gov record NCT03063008. Inclusion in this directory is not an endorsement.