Comparison of clinical outcome and radiographic between BMP-2 and beta-Tricalcium phosphate plus iliac bone graft in XLIF surgery

Recruiting

• Conditions: Fusion rate in patient who has spondylosis or spondylolithesis, and surgery lumbar spine by XLIF surgery (Extreme lateral interbody fusion) comparing between use BMP-2 and beta-tricalcium phosphate; spondylosis, lumbarsacral , BMP-2, beta tricalcium phosphate

• Registration Number: TCTR20240618007
• Lead Sponsor: Department of orthopedics surgery and physical therapy, Faculty of medicine Siriraj hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-18
• Last Update Posted: 19 August 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Patient who was diagnosed : Lumbar spondylosis, 2. Patient who was diagnosed : Lumbar spondylolithesis, 3. All patients who have undergone surgery XLIF

Exclusion Criteria

1. Patient who has severe complication in post-op surgery such as : Sepsis, Hemodynamic unstable, Stroke
2. Complication at post-operative follow up such as : Surgical site infection, Implant failure, Malignant at spine

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fusion rate 6 months, 12 months and 24 months after surgery Bridwell interbody fusion grading system,Fusion rate 6 months, 12 months and 24 months after surgery Film LS spine flexion and extension ( parameter such as lumbar lordosis, interforaminal distance)

Secondary Outcome Measures

Name	Time	Method
Clinical outcome 6 months, 12 months and 24 months after surgery ODI (Oswestry Disability Index) scoring,Clinical outcome 6 months, 12 months and 24 months after surgery EQ-5D-5L (Health-related quality of life measure),Pain score 6 months, 12 months and 24 months after surgery Pain NRS (Numeric rating scale)