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

NCT06532968 | Completed

• 1 other identifier: 2021-10-006C
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Oswestry Disability Index (ODI)

  Pre-surgery; one month after surgery; three months after surgery; six months after surgery

• Sort Form-12 Health Survey (SF-12)

  Pre-surgery; one month after surgery; three months after surgery; six months after surgery

Study Arms (2)

Control group

SHAM COMPARATOR

General spinal system

Device: Sham

LMC group

EXPERIMENTAL

General spinal system with ORION spinal lamina cover

Device: ORION spinal lamina cover

Interventions

Sham DEVICE

Sham

Control group

ORION spinal lamina cover DEVICE

an artificial lamina coverage of the ORION spinal system

LMC group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orion Biotech Inc.: lead
• Taipei Veterans General Hospital, Taiwan: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Spinal Stenosis; Scoliosis; Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spinal Curvatures; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Yu-Cheng Yao

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 1, 2024
• Study Start: March 30, 2022
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

TW (1)