Status:
COMPLETED
Clinical Evaluation of Orion Lamina Cover in Patients Undergoing Lumbar Laminectomy With Instrumented Fusion
Lead Sponsor:
Orion Biotech Inc.
Collaborating Sponsors:
Taipei Veterans General Hospital, Taiwan
Conditions:
Degenerative Lumbar Spinal Stenosis
Degenerative Spondylolisthesis
Eligibility:
All Genders
20+ years
Phase:
NA
Brief 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 ne...
Eligibility Criteria
Inclusion
- Gender and age: females and males are at least 20 years old
- Who with degenerative lumbar spondylolisthesis in one or two consecutive segments from lumbar vertebra L1 to sacral vertebra S1, and have objective evidence of back pain and numbness radiating to the lower limbs.
- Clinical symptoms of degenerative lumbar spondylolisthesis, accompanied by objective symptoms of neurological deficit; spinal stenosis, neurogenic claudication or bilateral radiating pain.
- Have received at least 3 months of non-surgical treatment without effectiveness.
- Radiographic examination was consistent with clinical symptoms of degenerative spondylolisthesis or spinal stenosis.
- After diagnosis who needs laminectomy with internal fixation and osseofusion
- Able and willing to sign the consent form and answer the questionnaire.
Exclusion
- Already had lumbar surgery at the same lumbar vertebra
- Physically health not well
- Probably pregnant
- Who suffering from malignant tumors or infections
- below 20 years old
- Unable and unwilling to answer the questionnaire and return to the hospital for treatment
- Unable to undergo MRI examination due to any reason, such as having a cardiac rhythm regulator, ferromagnetic implants, or claustrophobia.
Key Trial Info
Start Date :
March 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06532968
Start Date
March 30 2022
End Date
May 22 2024
Last Update
August 1 2024
Active Locations (1)
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1
Taipei Veterans General Hospital
Taipei, Taiwan