Degenerative SpondylolisthesisNCT03856554
Unilateral Versus Bilateral TLIF for Degenerative Lumbar Spondylolisthesis
A study testing Unilateral Transforaminal Interbody fusion and Bilateral Transforaminal Interbody fusion in people with Degenerative Spondylolisthesis and Transforaminal Lumbar Interbody Fusion, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
A prospective randomized controlled trial for comparison of radiologic outcomes of "single level transforaminal interbody fusion(TLIF) technique via unilateral versus bilateral facetectomy for the treatment of lumbar degenerative spondylolisthesis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Degenerative Spondylolisthesis, Transforaminal Lumbar Interbody Fusion
- What is being tested?
- Unilateral Transforaminal Interbody fusion and Bilateral Transforaminal Interbody fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jul 2017to 31 May 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- lumbar degenerative spondylolisthesis
- indicated for surgery
Who cannot join
- not agreed for the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Spine Center, Kyoungpook National University Hospital
Daegu
Woo-Kie Min, MD, PhD
About this study
Official title: Comparison of Radiologic and Clinical Outcome of Single Level Lumbar Interbody Fusion Between Unilateral or Bilateral Facetectomy : Prospective Randomized Controlled Trial
A prospective randomized controlled trial for comparison of radiologic outcomes of "single level transforaminal interbody fusion(TLIF) technique via unilateral versus bilateral facetectomy for the treatment of lumbar degenerative spondylolisthesis
Read the detailed description
Traditionally many spine surgeons prefer single level TLIF surgery via bilateral facetectomy for increasing union rate. Our hypothesis - "Single level TLIF via unilateral facetectomy is sufficient for achieve successful fusion rate"
- Being tested
- Unilateral Transforaminal Interbody fusion, Bilateral Transforaminal Interbody fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral Transforaminal Interbody fusionProcedure or surgery
TLIF via unilateral factectomy and insertion of one cage
Bilateral Transforaminal Interbody fusionProcedure or surgery
TLIF via bilateral factectomy and insertion of two cages
| Study group | Role | What they receive |
|---|---|---|
| Patients indicated for TLIF | Experimental | Patients with lumbar degenerative spondylolisthesis, indicated for TLIF surgery Receives: Procedure: Unilateral Transforaminal Interbody fusion; Procedure: Bilateral Transforaminal Interbody fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sagittal balance
Radiologic parameters
Measured: through study completion, an average of 1 year
Interbody fusion(union) failure
Radiologic parameters. Use dynamic plain X-ray. Union defined as no movement at segment
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Pain scores
Visual analog scale
Measured: through study completion, an average of 1 year
Functional scores
36-Item Short Form Survey (SF-36) Scoring
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start6 Jul 2017
- Primary completion31 May 2019 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative SpondylolisthesisStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Transforminal lumbar interbody fusion : unilateral versus bilateral facetectomy
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woo-Kie Min, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856554
- Sponsor's protocol ID
- KNUH 2017-04-021-004
- Status last verified
- Feb 2019
- First submitted
- 7 Mar 2018
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Radiologic and Clinical Outcome of Single Level Lumbar Interbody Fusion Between Unilateral or Bilateral Facetectomy : Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03856554
- Acronym / sponsor ID
- KNUH 2017-04-021-004
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 27 Feb 2019 (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.
A prospective randomized controlled trial for comparison of radiologic outcomes of "single level transforaminal interbody fusion(TLIF) technique via unilateral versus bilateral facetectomy for the treatment of lumbar degenerative spondylolisthesis
Detailed description
Traditionally many spine surgeons prefer single level TLIF surgery via bilateral facetectomy for increasing union rate. Our hypothesis - "Single level TLIF via unilateral facetectomy is sufficient for achieve successful fusion rate"
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Transforminal lumbar interbody fusion : unilateral versus bilateral facetectomy
| Arm | Type | Receives |
|---|---|---|
| Patients indicated for TLIF | Experimental | Procedure: Unilateral Transforaminal Interbody fusion, Procedure: Bilateral Transforaminal Interbody fusionPatients with lumbar degenerative spondylolisthesis, indicated for TLIF surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- lumbar degenerative spondylolisthesis
- indicated for surgery
Key exclusion criteria (1 listed)
- not agreed for the study
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 |
|---|---|---|
| Unilateral Transforaminal Interbody fusionTLIF via unilateral factectomy and insertion of one cage | Procedure or surgery | Patients indicated for TLIF |
| Bilateral Transforaminal Interbody fusionTLIF via bilateral factectomy and insertion of two cages | Procedure or surgery | Patients indicated for TLIF |
Primary outcome
Sagittal balance
Time frame: through study completion, an average of 1 year
Radiologic parameters
Interbody fusion(union) failure
Time frame: through study completion, an average of 1 year
Radiologic parameters. Use dynamic plain X-ray. Union defined as no movement at segment
2 secondary outcomes
Pain scores
Time frame: through study completion, an average of 1 year
Functional scores
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral Transforaminal Interbody fusion and Bilateral Transforaminal Interbody fusion in people with Degenerative Spondylolisthesis and Transforaminal Lumbar Interbody Fusion, run by Kyungpook National University Hospital at 1 site in South Korea.
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 2 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 27 Feb 2019. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Woo-Kie Min, MD, PhD (+82 53 420 5628, oswkmin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sagittal balance (time frame: through study completion, an average of 1 year). 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 27 Feb 2019.