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NCT Number: NCT06532968

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.

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Key information

Conditions

Degenerative Lumbar Spinal Stenosis Back Injuries Bone Diseases Degenerative Spondylolisthesis Fractures, Bone Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases Spinal Fracture Spinal Fractures Spinal Injuries Spinal Stenosis Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Veterans General Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHAM

Device

Sham

ORION spinal lamina cover

Device

an artificial lamina coverage of the ORION spinal system

Primary outcomes

  1. Magnetic Resonance Imaging (MRI)

    Time frame: Six months after surgery

    To observe the recovery of the participants' spine

  2. Visual Analogue Scale (VAS)

    Time frame: Pre-surgery; one month after surgery; three months after surgery; six months after surgery

    To measure the pain and numb of the participants' back and limbs

Secondary outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: Pre-surgery; one month after surgery; three months after surgery; six months after surgery

    To evaluate the functional disability of the participants' limbs

  2. Sort Form-12 Health Survey (SF-12)

    Time frame: Pre-surgery; one month after surgery; three months after surgery; six months after surgery

    To evaluate the physical health of the participants

Sponsors and collaborators

Lead sponsor

Orion Biotech Inc.

Industry

Collaborators

  • Taipei Veterans General Hospital, Taiwan

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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