Degenerative Lumbar Spinal StenosisNCT06532968
Clinical Evaluation of Orion Lamina Cover in Patients Undergoing Lumbar Laminectomy With Instrumented Fusion
A study testing ORION spinal lamina cover in people with Degenerative Lumbar Spinal Stenosis and Degenerative Spondylolisthesis, run by Orion Biotech Inc. at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Degenerative Lumbar Spinal Stenosis, Degenerative Spondylolisthesis, Spinal Stenosis
- What is being tested?
- ORION spinal lamina cover
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Mar 2022to 22 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Sham, ORION spinal lamina cover
- Medical subject headings
- Spinal Stenosis, Scoliosis, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShamDevice
Sham
ORION spinal lamina coverDevice
an artificial lamina coverage of the ORION spinal system
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | General spinal system Receives: Device: Sham |
| LMC group | Experimental | General spinal system with ORION spinal lamina cover Receives: Device: ORION spinal lamina cover |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Imaging (MRI)
To observe the recovery of the participants' spine
Measured: Six months after surgery
Visual Analogue Scale (VAS)
To measure the pain and numb of the participants' back and limbs
Measured: Pre-surgery; one month after surgery; three months after surgery; six months after surgery
Secondary outcomes (2)
Oswestry Disability Index (ODI)
To evaluate the functional disability of the participants' limbs
Measured: 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
Measured: Pre-surgery; one month after surgery; three months after surgery; six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start30 Mar 2022
- Primary completion22 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Responsible party
- Sponsor
- Investigators
- Yu-Cheng Yao, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532968
- Sponsor's protocol ID
- 2021-10-006C
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Orion Lamina Cover in Patients Undergoing Lumbar Laminectomy With Instrumented Fusion
- ClinicalTrials.gov ID
- NCT06532968
- Acronym / sponsor ID
- 2021-10-006C
- Conditions
- Degenerative Lumbar Spinal Stenosis, Degenerative Spondylolisthesis, Spinal Stenosis, Scoliosis, Spinal Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Orion Biotech Inc.Industry (pharma, biotech, devices)
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Device: ShamGeneral spinal system |
| LMC group | Experimental | Device: ORION spinal lamina coverGeneral spinal system with ORION spinal lamina cover |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShamSham | Device | Control group |
| ORION spinal lamina coveran artificial lamina coverage of the ORION spinal system | Device | LMC group |
Primary outcome
Magnetic Resonance Imaging (MRI)
Time frame: Six months after surgery
To observe the recovery of the participants' spine
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
2 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: Pre-surgery; one month after surgery; three months after surgery; six months after surgery
Sort Form-12 Health Survey (SF-12)
Time frame: Pre-surgery; one month after surgery; three months after surgery; six months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Cheng Yao principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ORION spinal lamina cover in people with Degenerative Lumbar Spinal Stenosis and Degenerative Spondylolisthesis, run by Orion Biotech Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic Resonance Imaging (MRI) (time frame: Six months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.