symptomatic lumbar degenerative disease level L2-S1 Spinal Fusion Interbody fusion Spinal Surgery Transforaminal Lumbar Interbody Fusion TLIF Cage Interbody Interbody Cage Interbody Spacer Spacer Implants PEEK Polyetheretherketone Titan
Conditions
Interventions
The patient will undergo MIS-
TLIF surgery. For the intervention group,
The patient will receive Titanium coated PEEK as an interbody spacer.,The patient will undergo MIS-
The patient will receive PEEK as an interbody spacer.
Experimental Device,Experimental Device
Ti-
PEEK,PEEK
Sponsors
none
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: symptomatic lumbar degenerative disease level L2-S1 who failed from properly treated with conservative treatment for more than 6 months age more than 18 years willingness to participate in the trial.
Exclusion criteria
Exclusion criteria: history of adjacent spine replacement within the previous 12 months serious systemic diseases or infectious/ inflammatory skin diseases in the area of the affected spine unable to assess subjective outcome and unable to complete follow-up program
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pain score, clinical score 6 and 12 months postoperation VAS score, ODI score, EQ-5D-5L | — |
Secondary
| Measure | Time frame |
|---|---|
| fusion rate, complication rate 6 and 12 months postoperation radiographic fusion will be assessed by CT scan | — |
Countries
Thailand
Contacts
Public ContactNattapat Tangchitcharoen
Orthopaedic department, Faculty of Medicine, Chulalongkorn University
Outcome results
None listed