NCT06532968

Clinical Evaluation of Orion Lamina Cover in Patients Undergoing Lumbar Laminectomy With Instrumented Fusion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Orion Biotech Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Laminectomy with internal fixation and osseofusion is a common surgery for treating degenerative spinal diseases. It removes excessive bone spurs and removes the lamina for decompression to relieve nerve compression, and then utilizes a spinal fixation system to stabilize the structure to relieve lower limb pain, paralysis, and other symptoms. However, the spinal cord that lacks lamina coverage after surgery is often compressed by scar tissue formation and hematoma, leading to postoperative back and lower limb pain. Therefore, this trial is divided into two groups, comparing the use of the cross connector of the ORION spinal system - the spinal lamina cover and the general spinal fixation system (without lamina cover). For participants undergoing laminectomy with internal fixation and osseofusion, after utilizing the spinal lamina cover of the ORION spinal system, whether the nerve compression caused by postoperative scar tissue formation and hematoma can be effectively reduced, and the pain in the back and lower limbs can be improved.

Conditions

• Degenerative Lumbar Spinal Stenosis
• Degenerative Spondylolisthesis
• Spinal Stenosis
• Scoliosis
• Spinal Fracture

Interventions

Type	Name	Description
DEVICE	Sham	Sham
DEVICE	ORION spinal lamina cover	an artificial lamina coverage of the ORION spinal system

Timeline

• Start date: 2022-03-30
• Primary completion: 2024-05-22
• Completion: 2024-05-22
• First posted: 2024-08-01
• Last updated: 2024-08-01

Locations

1 site across 1 country: Taiwan