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Comparison of Clinical and Radiographic Outcomes between Expandable and Static Cage for Oblique Lumbar Interbody Fusion; Randomized Controlled Trial

Comparison of Clinical and Radiographic Outcomes between Expandable and Static Cage for Oblique Lumbar Interbody Fusion; Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250526010
Enrollment
58
Registered
2025-05-26
Start date
2025-07-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative lumbar spinal stenosis Oblique Lateral Interbody Fusion OLIF Interbody Fusion Spinal Fusion Minimally Invasive Spine Surgery MISS Spinal Stenosis Intervertebral Disc replacement Randomized Controlled Trial RCT Clinical outcome Radiographic outcome Interbody spacer Cage Expandable Expandable cage Static cage Cage subsidence

Interventions

Intervertebral spacer (Cage) that can be expanded later after being inserted to intervertebral spaced in a narrowed form in order to reduce endplate violation and to increase disc height even more ,Co
Experimental Device,Active Comparator Device
Expandable cage,Static cage

Sponsors

Office of Research Affairs (ORA), Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age > 18 years old 2. Indicated for OLIF operation (diagnosed as degenerative lumbar spinal stenosis, degenerative disc disease, degenerative scoliosis, spondylolisthesis, etc.) 3. Undergoing single-level OLIF 4. Can adherent to at least 1 year follow up

Exclusion criteria

Exclusion criteria: 1. Other procedure is included in this operation; Endoscopic discectomy, etc. 2. Hx of any Lumbar spinal surgery 3. Has active infection / tumor at spine 4. Unable to co-operate or answering questionnaire or giving/denying consent

Design outcomes

Primary

MeasureTime frame
Cage subsidence rate 1 yr Defined as cage subsidence into either upper or lower vertebral endplate at least 2 mm

Secondary

MeasureTime frame
Visual analog scale (VAS) of back pain and leg pain Pre-op, Post-op 3 mo, 6 mo, 12 mo Questionnaire,Oswestry Disability Index (ODI) Pre-op, Post-op 3 mo, 6 mo, 12 mo Questionnaire,Anterior & Posterior disc height, Segmental lordosis (SL), Lumbar lordosis (LL), Translation Pre-op, immediate post op From plain film ,Dural sac area, Foraminal height, Foraminal area Pre-op, Post-op 3 mo MRI,Fusion rate Post-op 1 yr CT,Cage height and lordosis, Operative time, Blood loss Intra-operative Database

Countries

Thailand

Contacts

Public ContactJirayus Kittitadachaikul

Department of Orthopedics, King Chulalongkorn Memorial Hospital

jirayus.kit@chulahospital.org022564510

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026