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

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.

Study Overview

• Status: Completed
• Conditions: Scoliosis; Spinal Stenosis; Degenerative Spondylolisthesis; Degenerative Lumbar Spinal Stenosis; Spinal Fracture
• Intervention / Treatment: Device: Sham; Device: ORION spinal lamina cover

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control group; General spinal system	Device: Sham; Sham
Experimental: LMC group; General spinal system with ORION spinal lamina cover	Device: ORION spinal lamina cover; an artificial lamina coverage of the ORION spinal system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnetic Resonance Imaging (MRI)	To observe the recovery of the participants' spine	Six months after surgery
Visual Analogue Scale (VAS)	To measure the pain and numb of the participants' back and limbs	Pre-surgery; one month after surgery; three months after surgery; six months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI)	To evaluate the functional disability of the participants' limbs	Pre-surgery; one month after surgery; three months after surgery; six months after surgery
Sort Form-12 Health Survey (SF-12)	To evaluate the physical health of the participants	Pre-surgery; one month after surgery; three months after surgery; six months after surgery

Collaborators and Investigators

• Sponsor: Orion Biotech Inc.
• Collaborators: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Yu-Cheng Yao, Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Actual): May 22, 2024
• Study Completion (Actual): May 22, 2024

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Spinal Curvatures; Spinal Injuries; Back Injuries; Spondylolysis; Spondylosis; Scoliosis; Constriction, Pathologic; Spinal Stenosis; Spinal Fractures; Spondylolisthesis
• Other Study ID Numbers: 2021-10-006C

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No