MedTrace Logo

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

NCT06532968 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-01

No results posted yet for this study

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

DEVICE

Sham

Sham

DEVICE

ORION spinal lamina cover

an artificial lamina coverage of the ORION spinal system

Sponsors & Collaborators

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • Orion Biotech Inc.

    lead INDUSTRY

Principal Investigators

  • Yu-Cheng Yao · Taipei Veterans General Hospital, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-30
Primary Completion
2024-05-22
Completion
2024-05-22

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06532968 on ClinicalTrials.gov