Lumbar Foraminal StenosisNCT02985138
Comparison of Unilateral or Bilateral Fixation in the Treatment of LFS
A study testing TLIF and unilateral pedicle screw fixation, TLIF and bilateral pedicle screw fixation and Pedicle screw and cage in people with Lumbar Foraminal Stenosis, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
TLIF is a popular lumbar fusion technique to perform interbody fusion. Pedicle screws providing initial stability have been developed to correct deformity, improve the rate of fusion and speed patient's postoperative recovery. Conventionally, bilateral pedicle screw fixation is a standard approach. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lumbar Foraminal Stenosis
- What is being tested?
- TLIF and unilateral pedicle screw fixation, TLIF and bilateral pedicle screw fixation and Pedicle screw and cage
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Sep 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Patient is willing to be available for each examination scheduled over the study duration.
- Lumbar foraminal stenosis diagnosed by patient history, physical examination and image confirmation.
- Patient has symptoms referable to the stenosis level (low back pain, leg pain, tingling, numbness or weakness), which are relieved after a selective nerve root block.
- Has not responded to conservative treatment for a period of 3 months (e.g. bed rest, physical therapy, medication, manipulations, other).
Who cannot join
- Has systemic infection, highly communicable diseases, inflammatory or autoimmune disease (e.g. osteomyelitis, crohn's, rheumatoid arthritis, systemic lupus, gout, HIV/AIDS, active tuberculosis, venereal disease, active hepatitis).
- Has presence of active malignancy
- Has a history of severe allergy
- Has a significant medical history that, in the investigator's opinion, would not make them a good study candidate.
- Pregnant, or may become pregnant within follow-up period of study
- Has other spinal conditions that will interfere with clinical outcomes (e.g. spinal structural deformities, spinal fractures, ankylosing spondylitis, spinal tuberculosis, spinal infection, spinal tumors, symptomatic cervical spinal disease)
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- Spondylolisthesis at the target level
- Has undergone previous lumbar surgery
- Has severe osteoporosis (T-score ≤ -3.5)
- BMI > 35kg/m2
- Has a diagnosis, which requires postoperative medication that interferes with fusion, such as steroids.
- Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers-Danios syndrome or osteogenesis imperfecta)
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Orthopedic Surgery, Shanghai Ninth People's Hospital
Shanghai, 200011
About this study
Official title: Comparison of Unilateral or Bilateral Fixation Using Pedicle Screws and TLIF in the Treatment of Lumbar Foraminal Stenosis
TLIF is a popular lumbar fusion technique to perform interbody fusion. Pedicle screws providing initial stability have been developed to correct deformity, improve the rate of fusion and speed patient's postoperative recovery. Conventionally, bilateral pedicle screw fixation is a standard approach. Recently, studies have revealed that unilateral pedicle screw fixation provides equivalent clinical outcomes and fusion rates as compared with bilateral pedicle screw fixation in lumbar fusion. Meanwhile, the unilateral approach can reduce intraoperative blood loss and operating time. To our knowledge, few randomized controlled studies comparing unilateral versus bilateral instrumented TLIF in lumbar degenerative diseases have been reported. The purpose of this study is to compare clinical and radiographic outcomes in a series of patients with lumbar foraminal stenosis using instrumented TLIF with unilateral or bilateral pedicle screw fixation.
- Conditions
- Lumbar Foraminal Stenosis
- Being tested
- TLIF and unilateral pedicle screw fixation, TLIF and bilateral pedicle screw fixation, Pedicle screw and cage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLIF and unilateral pedicle screw fixationProcedure or surgery
TLIF combined with posterior unilateral pedicle screw fixation
TLIF and bilateral pedicle screw fixationProcedure or surgery
TLIF combined with posterior bilateral pedicle screw fixation
Pedicle screw and cageDevice
Pedicle screw and cage
| Study group | Role | What they receive |
|---|---|---|
| Unilateral fixation | Experimental | Patients undergoing TLIF and unilateral pedicle screw fixation Receives: Procedure: TLIF and unilateral pedicle screw fixation; Device: Pedicle screw and cage |
| Bilateral fixation | Active comparator | Patients undergoing TLIF and bilateral pedicle screw fixation Receives: Procedure: TLIF and bilateral pedicle screw fixation; Device: Pedicle screw and cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) scores
Measured: 2 years postoperatively
Secondary outcomes (10)
Adverse events related to procedure
Measured: 2 years postoperatively
Operative duration
Measured: 1 week postoperatively
Estimated blood loss
Measured: 1 week postoperatively
Length of hospital stay
Measured: 1 week after discharge
Spinal angles
Radiographic parameters
Measured: 2 years postoperatively
Intervertebral space height
Radiographic parameters
Measured: 2 years postoperatively
Foraminal height
Radiographic parameters
Measured: 2 years postoperatively
Cost of treatment
Measured: 2 years postoperatively
Fusion rate
Measured: 2 years postoperatively
Oswestry Disability Index (ODI)
Measured: 2 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionSep 2021
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Foraminal StenosisStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaofei Cheng, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985138
- Sponsor's protocol ID
- SNPHO-161116
- Status last verified
- Jan 2022
- First submitted
- 23 Nov 2016
- Last updated
- 25 Jan 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Unilateral or Bilateral Fixation Using Pedicle Screws and TLIF in the Treatment of Lumbar Foraminal Stenosis
- ClinicalTrials.gov ID
- NCT02985138
- Acronym / sponsor ID
- SNPHO-161116
- Conditions
- Lumbar Foraminal Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Sep 2021 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 7 Dec 2016 (estimated)
- 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.
TLIF is a popular lumbar fusion technique to perform interbody fusion. Pedicle screws providing initial stability have been developed to correct deformity, improve the rate of fusion and speed patient's postoperative recovery. Conventionally, bilateral pedicle screw fixation is a standard approach. Recently, studies have revealed that unilateral pedicle screw fixation provides equivalent clinical outcomes and fusion rates as compared with bilateral pedicle screw fixation in lumbar fusion. Meanwhile, the unilateral approach can reduce intraoperative blood loss and operating time. To our knowledge, few randomized controlled studies comparing unilateral versus bilateral instrumented TLIF in lumbar degenerative diseases have been reported. The purpose of this study is to compare clinical and radiographic outcomes in a series of patients with lumbar foraminal stenosis using instrumented TLIF with unilateral or bilateral pedicle screw fixation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral fixation | Experimental | Procedure: TLIF and unilateral pedicle screw fixation, Device: Pedicle screw and cagePatients undergoing TLIF and unilateral pedicle screw fixation |
| Bilateral fixation | Active comparator | Procedure: TLIF and bilateral pedicle screw fixation, Device: Pedicle screw and cagePatients undergoing TLIF and bilateral pedicle screw fixation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent.
- Patient is willing to be available for each examination scheduled over the study duration.
- Lumbar foraminal stenosis diagnosed by patient history, physical examination and image confirmation.
- Patient has symptoms referable to the stenosis level (low back pain, leg pain, tingling, numbness or weakness), which are relieved after a selective nerve root block.
- Has not responded to conservative treatment for a period of 3 months (e.g. bed rest, physical therapy, medication, manipulations, other).
Key exclusion criteria (12 listed)
- Has systemic infection, highly communicable diseases, inflammatory or autoimmune disease (e.g. osteomyelitis, crohn's, rheumatoid arthritis, systemic lupus, gout, HIV/AIDS, active tuberculosis, venereal disease, active hepatitis).
- Has presence of active malignancy
- Has a history of severe allergy
- Has a significant medical history that, in the investigator's opinion, would not make them a good study candidate.
- Pregnant, or may become pregnant within follow-up period of 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 |
|---|---|---|
| TLIF and unilateral pedicle screw fixationTLIF combined with posterior unilateral pedicle screw fixation | Procedure or surgery | Unilateral fixation |
| TLIF and bilateral pedicle screw fixationTLIF combined with posterior bilateral pedicle screw fixation | Procedure or surgery | Bilateral fixation |
| Pedicle screw and cagePedicle screw and cage | Device | Bilateral fixation, Unilateral fixation |
Primary outcome
Visual Analogue Scale (VAS) scores
Time frame: 2 years postoperatively
10 secondary outcomes
Adverse events related to procedure
Time frame: 2 years postoperatively
Operative duration
Time frame: 1 week postoperatively
Estimated blood loss
Time frame: 1 week postoperatively
Length of hospital stay
Time frame: 1 week after discharge
Spinal angles
Time frame: 2 years postoperatively
Intervertebral space height
Time frame: 2 years postoperatively
Foraminal height
Time frame: 2 years postoperatively
Cost of treatment
Time frame: 2 years postoperatively
Fusion rate
Time frame: 2 years postoperatively
Oswestry Disability Index (ODI)
Time frame: 2 years postoperatively
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 25 Jan 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TLIF and unilateral pedicle screw fixation, TLIF and bilateral pedicle screw fixation and Pedicle screw and cage in people with Lumbar Foraminal Stenosis, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University 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 5 inclusion and 12 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 25 Jan 2022. 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?
Visual Analogue Scale (VAS) scores (time frame: 2 years postoperatively). 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 25 Jan 2022.