Efficacy of PRP for bone fusion in LLIF

Completed

• Conditions: vertebral fracture, lumbar canal stenosis, lumbar spondylolisthesis, adult spine deformity

• Registration Number: jRCTb032200199

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-13
• Study Start: 2021-02-01
• Last Update Posted: 2024-03-31

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Patients who receives lateral lumbar interbody fusion surgery for vertebral fracture, lumbar canal stenosis, lumbar spondylolisthesis, adult spine deformity, and so on
2. Patients who receives lateral lumbar interbody fusion surgery at 1-4 levels
3. Patients over 20 years old
4. Patients with informed concent and understanding for treatment

Exclusion Criteria

1. Patients with a history of lumbar surgery, purulent spondylitis, or spinal tumor
2. Patients who received other Investigational new drug within 3 months of participating in this clinical study
3. Patients who have a primary illness that is clearly inferior to bone formation (bone metabolic disease, dialysis, and so on)
4. Patients who have uncontrolled diabetes
5. Patients with anemia (Hb<9.0g/dL)
6. Patients who have disorder of blood coagulation.
7. Patients with rheumatoid arthritis who are using biologics with high risk of perioperative infection.
8. Women who are pregnant or suspected ofbeing pregnant or breastfeeding
9. Patients with metal allergy
10. Patients who needs the legal representative
11. Patients who are judged inappropriate by the responsible doctor for the study

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
-		Interbody fusion rate at postoperative 12 months

Secondary Outcome Measures

Name	Time	Method
Interbody fusion rate	postoperative 6 months	Interbody fusion rate at postoperative 6 months
bone remodeling and Absorption of artificial bone		bone remodeling and Absorption of artificial bone
Contact between the implanted beta-TCP and both upper and lower vertebral endplate		Contact between the implanted beta-TCP and both upper and lower vertebral endplate
Clinical outcomes		Clinical outcomes
back pain		back pain (Visual analog scale)