Spinal StenosisNCT06290908
RPE-P/TLIF for Lumbar Spinal Stenosis With Instability
An observational study of Spinal Stenosis, run by Wen-xi Sun at 1 site in China.
Trial summary
Objective To analyze the effectiveness and safety of robot-assisted percutaneous endoscopic posterior/transforaminal lumbar interbody fusion (RPE-P/TLIF) in the treatment of lumbar spinal stenosis with instability. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- RPE-P/TLIF
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2018to 1 Feb 2024
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study included patients with clinical manifestations of intermittent claudication accompanied by lower back pain, lumbar spine MRI and/or CT findings of lumbar spinal stenosis, and X-ray images of over extension and over flexion indicating responsible segment lumbar instability. Symptoms were severe, affecting daily life and work, and conservative treatment was ineffective. RPE-P/TLIF single or double segment surgery was performed.
Who may be able to join
- Patients who present with intermittent claudication accompanied by lower back pain, lumbar spine MRI and/or CT findings of lumbar spinal stenosis, and X-ray images of over extension and over flexion indicating instability of the responsible segment of the lumbar spine, have severe symptoms that affect daily life and work, and have poor conservative treatment results. Therefore, RPE-P/TLIF single segment or double segment surgical treatment is recommended.
Who cannot join
- Simple lumbar spinal stenosis without responsible segment instability; (2) Long segment (3 or more) spinal stenosis with lumbar instability; (3) Patients with major internal medicine underlying diseases who cannot tolerate surgery; (4) Individuals with comorbid mental disorders or Alzheimer's disease who are unable to cooperate with relevant scale filling and subsequent follow-up; (5) Age<18 years old.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou
About this study
Official title: Robot-assisted Percutaneous Endoscopic Posterior/Transforaminal Lumbar Interbody Fusion for Lumbar Spinal Stenosis With Instability
Objective To analyze the effectiveness and safety of robot-assisted percutaneous endoscopic posterior/transforaminal lumbar interbody fusion (RPE-P/TLIF) in the treatment of lumbar spinal stenosis with instability. Methods A single-center prospective study from September 2018 to April 2022, patients with lumbar spinal stenosis and instability who met the inclusion and exclusion criteria were treated with RPE-P/TLIF. Pain visual analog scale (VAS) was used to evaluate the degree of low back pain and lower limb pain before operation, 1 month, 6 months, 1 year after operation and at the final follow-up, and the Oswestry disability index (ODI) was used to evaluate the degree of lumbar spinal function. At the last follow-up, MacNab criteria were used to evaluate the clinical efficacy. Imaging evaluation included the measurement of intervertebral space height, lumbar physiological curvature, fusion rate and pedicle screw accuracy by preoperative and lateral X-ray films.
- Conditions
- Spinal Stenosis
- Being tested
- RPE-P/TLIF
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPE-P/TLIFProcedure or surgery
patients with lumbar spinal stenosis and instability who met the inclusion and exclusion criteria were treated with RPE-P/TLIF
| Study group | Role | What they receive |
|---|---|---|
| RPE-P/TLIF | The clinical manifestation is intermittent claudication accompanied by lower back pain. Patients with lumbar spinal canal stenosis indicated by MRI and/or CT, and instability of the responsible segment of the lumbar spine shown by X-ray in the over extension and over flexion position, with severe symptoms that affect daily life and work, and poor conservative treatment effect, should undergo RPE-P/TLIF single or double segment surgical treatment. Receives: Procedure: RPE-P/TLIF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain visual analog scale (VAS)
Pain assessment, assessing lower back pain and lower limb pain.
Measured: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
Secondary outcomes (6)
Oswestry disability index (ODI)
Evaluate neurological function
Measured: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
MacNab criteria
The overall efficacy rate was evaluated using the modified MacNab criteria, which were divided into four levels: excellent, good, fair, and poor. Among them, excellent was the complete disappearance of symptoms and the restoration of normal life; Liangwei still has mild symptoms and mild activity restriction, but has no impact on life and work; May still have obvious symptoms, limited activities, and affect normal life and work; Poor symptoms do not improve, activities do not improve, and even worsen.
Measured: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
intervertebral space height
Imaging evaluation indicators:
Measured: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
lumbar physiological curvature
Imaging evaluation indicators:
Measured: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
fusion rate
Imaging evaluation indicators:
Measured: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
pedicle screw accuracy
Imaging evaluation indicators:
Measured: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start4 Sep 2018
- Primary completion30 Apr 2022
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wen-xi Sun
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor-investigator, Wen-xi Sun, Guangzhou University of Chinese Medicine
- Investigators
- Yong-peng Lin, dr, Study chair, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290908
- Sponsor's protocol ID
- TF2018-001-01
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are considering sharing our IPD after the data statistics are completed.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted Percutaneous Endoscopic Posterior/Transforaminal Lumbar Interbody Fusion for Lumbar Spinal Stenosis With Instability
- ClinicalTrials.gov ID
- NCT06290908
- Acronym / sponsor ID
- TF2018-001-01
- Conditions
- Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Wen-xi SunUniversity, hospital or other
- Collaborators
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 4 Mar 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.
Objective To analyze the effectiveness and safety of robot-assisted percutaneous endoscopic posterior/transforaminal lumbar interbody fusion (RPE-P/TLIF) in the treatment of lumbar spinal stenosis with instability. Methods A single-center prospective study from September 2018 to April 2022, patients with lumbar spinal stenosis and instability who met the inclusion and exclusion criteria were treated with RPE-P/TLIF. Pain visual analog scale (VAS) was used to evaluate the degree of low back pain and lower limb pain before operation, 1 month, 6 months, 1 year after operation and at the final follow-up, and the Oswestry disability index (ODI) was used to evaluate the degree of lumbar spinal function. At the last follow-up, MacNab criteria were used to evaluate the clinical efficacy. Imaging evaluation included the measurement of intervertebral space height, lumbar physiological curvature, fusion rate and pedicle screw accuracy by preoperative and lateral X-ray films.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RPE-P/TLIF | – | Procedure: RPE-P/TLIFThe clinical manifestation is intermittent claudication accompanied by lower back pain. Patients with lumbar spinal canal stenosis indicated by MRI and/or CT, and instability of the responsible segment of the lumbar spine shown by X-ray in the over extension and over flexion position, with severe symptoms that affect daily life and work, and poor conservative treatment effect, should undergo RPE-P/TLIF single or double segment surgical treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study included patients with clinical manifestations of intermittent claudication accompanied by lower back pain, lumbar spine MRI and/or CT findings of lumbar spinal stenosis, and X-ray images of over extension and over flexion indicating responsible segment lumbar instability. Symptoms were severe, affecting daily life and work, and conservative treatment was ineffective. RPE-P/TLIF single or double segment surgery was performed.
Key inclusion criteria (1 listed)
- Patients who present with intermittent claudication accompanied by lower back pain, lumbar spine MRI and/or CT findings of lumbar spinal stenosis, and X-ray images of over extension and over flexion indicating instability of the responsible segment of the lumbar spine, have severe symptoms that affect daily life and work, and have poor conservative treatment results. Therefore, RPE-P/TLIF single segment or double segment surgical treatment is recommended.
Key exclusion criteria (1 listed)
- Simple lumbar spinal stenosis without responsible segment instability; (2) Long segment (3 or more) spinal stenosis with lumbar instability; (3) Patients with major internal medicine underlying diseases who cannot tolerate surgery; (4) Individuals with comorbid mental disorders or Alzheimer's disease who are unable to cooperate with relevant scale filling and subsequent follow-up; (5) Age<18 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 |
|---|---|---|
| RPE-P/TLIFpatients with lumbar spinal stenosis and instability who met the inclusion and exclusion criteria were treated with RPE-P/TLIF | Procedure or surgery | RPE-P/TLIF |
Primary outcome
Pain visual analog scale (VAS)
Time frame: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
Pain assessment, assessing lower back pain and lower limb pain.
6 secondary outcomes
Oswestry disability index (ODI)
Time frame: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
MacNab criteria
Time frame: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
intervertebral space height
Time frame: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
lumbar physiological curvature
Time frame: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
fusion rate
Time frame: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
pedicle screw accuracy
Time frame: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years 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 4 Mar 2024.
- Individual participant dataSharing planned: Undecided. We are considering sharing our IPD after the data statistics are completed.
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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.
Yong-peng Lin, dr study chair
Guangdong Provincial Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Stenosis, run by Wen-xi Sun at 1 site in China.
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 1 inclusion and 1 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 4 Mar 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 China. 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. 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?
Pain visual analog scale (VAS) (time frame: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery). 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 4 Mar 2024.