Lumbar SpondylolisthesisNCT02972190
Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis
A study testing Bilateral decompression with TLIF, laminectomy with PLIF and Pedicle screw and interbody cage in people with Lumbar Spondylolisthesis, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
Laminectomy with PLIF has been shown to achieve satisfactory clinical outcomes, but it leads to potential adverse consequences associated with extensive disruption of posterior bony and soft-tissue structures. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lumbar Spondylolisthesis
- What is being tested?
- Bilateral decompression with TLIF, laminectomy with PLIF and Pedicle screw and interbody cage
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Oct 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lumbar spondylolisthesis
- symptoms of low back pain and/or neurogenic claudication with or without radiculopathy referable to the lumbar spine,
- at least 3 months of failed conservative therapies
Who cannot join
- multilevel lumbar degenerative diseases
- history of previous lumbar surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Orthopedic Surgery, Shanghai Ninth People's Hospital
Shanghai, 200011
Xiaofei Cheng, MD, 8613917556604, chengxf2015@163.com
About this study
Laminectomy with PLIF has been shown to achieve satisfactory clinical outcomes, but it leads to potential adverse consequences associated with extensive disruption of posterior bony and soft-tissue structures. The investigators plan to compare the clinical and radiographic outcomes of bilateral decompression with transforaminal lumbar interbody fusion and laminectomy with posterior lumbar interbody fusion in the treatment of degenerative spondylolisthesis.
- Conditions
- Lumbar Spondylolisthesis
- Being tested
- Bilateral decompression with TLIF, laminectomy with PLIF, Pedicle screw and interbody cage
- Medical subject headings
- Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral decompression with TLIFProcedure or surgery
Bilateral decompression of neural elements combined with TLIF
laminectomy with PLIFProcedure or surgery
Decompression of neural elements using laminectomy combined with PLIF
Pedicle screw and interbody cageDevice
Pedicle screw and interbody cage
| Study group | Role | What they receive |
|---|---|---|
| Bilateral decompression with TLIF | Experimental | Patients undergoing bilateral decompression with TLIF Receives: Procedure: Bilateral decompression with TLIF; Device: Pedicle screw and interbody cage |
| laminectomy with PLIF | Active comparator | Patients undergoing laminectomy with PLIF Receives: Procedure: laminectomy with PLIF; Device: Pedicle screw and interbody cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale for low back pain and leg pain
Measured: 2 years postoperatively
Oswestry disability index
Measured: 2 years postoperatively
Zurich claudication questionnaire
Measured: 2 years postoperatively
SF-36 score
Measured: 2 years postoperatively
Fusion rate
Measured: 2 years postoperatively
Secondary outcomes (7)
Surgery procedure duration
Measured: Intraoperation
Estimated blood loss
Measured: Intraoperation
Length of postoperative hospital stay
Measured: 1 week after hospital discharge
Complication
Measured: 2 years postoperatively
Degree of spondylolisthesis measured by X ray
Measured: 2 years postoperatively
Disc space height measured by X ray
Measured: 2 years postoperatively
Lumbar lordosis measured by X ray
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 posted23 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2018 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar SpondylolisthesisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
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
- NCT02972190
- Sponsor's protocol ID
- SNPHO-161107
- Status last verified
- Nov 2016
- First submitted
- 7 Nov 2016
- Last updated
- 28 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis
- ClinicalTrials.gov ID
- NCT02972190
- Acronym / sponsor ID
- SNPHO-161107
- Conditions
- Lumbar Spondylolisthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 23 Nov 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.
Laminectomy with PLIF has been shown to achieve satisfactory clinical outcomes, but it leads to potential adverse consequences associated with extensive disruption of posterior bony and soft-tissue structures. The investigators plan to compare the clinical and radiographic outcomes of bilateral decompression with transforaminal lumbar interbody fusion and laminectomy with posterior lumbar interbody fusion in the treatment of degenerative spondylolisthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral decompression with TLIF | Experimental | Procedure: Bilateral decompression with TLIF, Device: Pedicle screw and interbody cagePatients undergoing bilateral decompression with TLIF |
| laminectomy with PLIF | Active comparator | Procedure: laminectomy with PLIF, Device: Pedicle screw and interbody cagePatients undergoing laminectomy with PLIF |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- lumbar spondylolisthesis
- symptoms of low back pain and/or neurogenic claudication with or without radiculopathy referable to the lumbar spine,
- at least 3 months of failed conservative therapies
Key exclusion criteria (2 listed)
- multilevel lumbar degenerative diseases
- history of previous lumbar surgery
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 |
|---|---|---|
| Bilateral decompression with TLIFBilateral decompression of neural elements combined with TLIF | Procedure or surgery | Bilateral decompression with TLIF |
| laminectomy with PLIFDecompression of neural elements using laminectomy combined with PLIF | Procedure or surgery | laminectomy with PLIF |
| Pedicle screw and interbody cagePedicle screw and interbody cage | Device | Bilateral decompression with TLIF, laminectomy with PLIF |
Primary outcome
visual analog scale for low back pain and leg pain
Time frame: 2 years postoperatively
Oswestry disability index
Time frame: 2 years postoperatively
Zurich claudication questionnaire
Time frame: 2 years postoperatively
SF-36 score
Time frame: 2 years postoperatively
Fusion rate
Time frame: 2 years postoperatively
7 secondary outcomes
Surgery procedure duration
Time frame: Intraoperation
Estimated blood loss
Time frame: Intraoperation
Length of postoperative hospital stay
Time frame: 1 week after hospital discharge
Complication
Time frame: 2 years postoperatively
Degree of spondylolisthesis measured by X ray
Time frame: 2 years postoperatively
Disc space height measured by X ray
Time frame: 2 years postoperatively
Lumbar lordosis measured by X ray
Time frame: 2 years postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
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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 Bilateral decompression with TLIF, laminectomy with PLIF and Pedicle screw and interbody cage in people with Lumbar Spondylolisthesis, 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 3 inclusion and 2 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 28 Nov 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaofei Cheng, MD (8613917556604, chengxf2015@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale for low back pain and leg pain (time frame: 2 years postoperatively). The study lists 5 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 28 Nov 2016.