Lumbar Spinal StenosisNCT04778943
Oblique Lateral Interbody Fusion Versus Minimally Invasive Transforaminal Lumbar Interbody Fusion
An observational study of Lumbar Spinal Stenosis, run by Tang-Du Hospital.
Trial summary
The investigators will retrospectively study lumbar spinal stenosis patients who underwent OLIF or MIS-TLIF with percutaneous pedicle screw fixation between January 2016 and December 2019.The investigators will measure estimated blood loss, operative time, hospital stay, cost, reoperation, and complication incidence… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Surgery(OLIF and MIS-TLIF)
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2021to 29 Mar 2021
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were diagnosed with LSS and underwent either MIS-TLIF or OLIF surgery between January 2016 and December 2019.
Who may be able to join
- LSS due to neurogenic claudication; Central stenosis or lateral stenosis who need surgery; Single-level, low-grade (Meyerding grade 1 or 2) isthmic spondylolisthesis or degenerative spondylolisthesis; and imaging findings consistent with the symptoms of LSS.
Who cannot join
- trauma, active infection, malignant tumors, spinal deformity, previous lumbar fusion, multi-segment fusion, multi-level, high-grade (Meyerding grade 3 or 4) isthmic spondylolisthesis or degenerative spondylolisthesis.
About this study
Official title: Oblique Lateral Interbody Fusion Versus Minimally Invasive Transforaminal Lumbar Interbody Fusion for Lumbar Spinal Stenosis
The investigators will retrospectively study lumbar spinal stenosis patients who underwent OLIF or MIS-TLIF with percutaneous pedicle screw fixation between January 2016 and December 2019.The investigators will measure estimated blood loss, operative time, hospital stay, cost, reoperation, and complication incidence, visual analogue scale (VAS), Oswestry Disability Index (ODI), Japanese Orthopaedic Association (JOA), and Short Form-36 (SF-36) scores, discal and foraminal height, lumbar lordotic angle, and fusion status.The investigators will conduct to evaluate postoperative improvements, complications, and reoperation rates between patients with lumbar spinal stenosis (LSS) undergoing oblique lateral interbody fusion (OLIF) or minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF).
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Surgery(OLIF and MIS-TLIF)
- Keywords
- Lumbar spinal stenosis, OLIF, MIS-TLIF, postoperative improvements
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery(OLIF and MIS-TLIF)Other
oblique lateral interbody fusion (OLIF); minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF)
| Study group | Role | What they receive |
|---|---|---|
| oblique lateral interbody fusion (OLIF) | Patients with lumbar spinal stenosis undergoing oblique lateral interbody fusion (OLIF) Receives: Other: Surgery(OLIF and MIS-TLIF) | |
| minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) | Patients with lumbar spinal stenosis undergoing minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) Receives: Other: Surgery(OLIF and MIS-TLIF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI), , and Short Form-36 (SF-36) scores; discal and foraminal height; lumbar lordotic angle; and fusion status.
Before surgery and at the last follow-up, the following information was recorded
Measured: 2 Years
Secondary outcomes (4)
Japanese Orthopaedic Association (JOA)
Before surgery and at the last follow-up, the following information was recorded
Measured: 2 Years
visual analogue scale (VAS)
Before surgery and at the last follow-up, the following information was recorded
Measured: 2 Years
Short Form-36 (SF-36) scores
Before surgery and at the last follow-up, the following information was recorded
Measured: 2 Years
Major Complication rate
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start28 Feb 2021 (estimated)
- Primary completion25 Mar 2021 (estimated)
- Study completion29 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei-Long Wei, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778943
- Sponsor's protocol ID
- TDGKJZ
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oblique Lateral Interbody Fusion Versus Minimally Invasive Transforaminal Lumbar Interbody Fusion for Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT04778943
- Acronym / sponsor ID
- TDGKJZ
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Lumbar spinal stenosis, OLIF, MIS-TLIF, postoperative improvements
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 28 Feb 2021 (estimated)
- Primary completion
- 25 Mar 2021 (estimated)
- Study completion
- 29 Mar 2021 (estimated)
- First posted
- 3 Mar 2021 (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.
The investigators will retrospectively study lumbar spinal stenosis patients who underwent OLIF or MIS-TLIF with percutaneous pedicle screw fixation between January 2016 and December 2019.The investigators will measure estimated blood loss, operative time, hospital stay, cost, reoperation, and complication incidence, visual analogue scale (VAS), Oswestry Disability Index (ODI), Japanese Orthopaedic Association (JOA), and Short Form-36 (SF-36) scores, discal and foraminal height, lumbar lordotic angle, and fusion status.The investigators will conduct to evaluate postoperative improvements, complications, and reoperation rates between patients with lumbar spinal stenosis (LSS) undergoing oblique lateral interbody fusion (OLIF) or minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oblique lateral interbody fusion (OLIF) | – | Other: Surgery(OLIF and MIS-TLIF)Patients with lumbar spinal stenosis undergoing oblique lateral interbody fusion (OLIF) |
| minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) | – | Other: Surgery(OLIF and MIS-TLIF)Patients with lumbar spinal stenosis undergoing minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were diagnosed with LSS and underwent either MIS-TLIF or OLIF surgery between January 2016 and December 2019.
Key inclusion criteria (1 listed)
- LSS due to neurogenic claudication; Central stenosis or lateral stenosis who need surgery; Single-level, low-grade (Meyerding grade 1 or 2) isthmic spondylolisthesis or degenerative spondylolisthesis; and imaging findings consistent with the symptoms of LSS.
Key exclusion criteria (1 listed)
- trauma, active infection, malignant tumors, spinal deformity, previous lumbar fusion, multi-segment fusion, multi-level, high-grade (Meyerding grade 3 or 4) isthmic spondylolisthesis or degenerative spondylolisthesis.
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 |
|---|---|---|
| Surgery(OLIF and MIS-TLIF)oblique lateral interbody fusion (OLIF); minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) | Other | minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF), oblique lateral interbody fusion (OLIF) |
Primary outcome
Oswestry Disability Index (ODI), , and Short Form-36 (SF-36) scores; discal and foraminal height; lumbar lordotic angle; and fusion status.
Time frame: 2 Years
Before surgery and at the last follow-up, the following information was recorded
4 secondary outcomes
Japanese Orthopaedic Association (JOA)
Time frame: 2 Years
visual analogue scale (VAS)
Time frame: 2 Years
Short Form-36 (SF-36) scores
Time frame: 2 Years
Major Complication rate
Time frame: 2 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis, run by Tang-Du Hospital.
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: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Oswestry Disability Index (ODI), , and Short Form-36 (SF-36) scores; discal and foraminal height; lumbar lordotic angle; and fusion status. (time frame: 2 Years). 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 3 Mar 2021.