Degenerative SpondylolisthesisNCT02530775
"Is Instrumentation Necessary for "Static" Degenerative Spondylolisthesis"
A study testing instrumented spinal fusion with laminectomy and non-instrumented spinal fusion with laminectomy in people with Degenerative Spondylolisthesis and Spinal Stenosis, run by University of Pittsburgh.
Trial summary
The purpose of this study is to determine whether instrumented lumbar fusion provides superior clinical outcomes in comparison to non-instrumented fusion in patients with "static" degenerative spondylolisthesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Spondylolisthesis, Spinal Stenosis
- What is being tested?
- instrumented spinal fusion with laminectomy and non-instrumented spinal fusion with laminectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stable L4-5 spondylolisthesis on lumbar flexion and extension radiographs. Stability will be determined by the treating physician.
- Patients with concomitant spinal stenosis.
- Laminectomy at any lumbar levels of stenosis.
- Fusion only at L4-5 level.
Who cannot join
- Prior lumbar spine surgery
- Multi-level spondylolisthesis
- Anterior interbody work/fusion
- Tumor
- Infection
- Trauma
About this study
Official title: "Is Instrumentation Necessary for "Static" Degenerative Spondylolisthesis - A Prospective Randomized Clinical Study"
The purpose of this study is to determine whether instrumented lumbar fusion provides superior clinical outcomes in comparison to non-instrumented fusion in patients with "static" degenerative spondylolisthesis.
Read the detailed description
This study will determine whether instrumented lumbar fusion will provide superior clinical outcomes in comparison to non-instrumented fusion in patients with "STATIC" degenerative spondylolisthesis. At the time of scheduling surgery, patients who meet the inclusion/exclusion criteria will be asked to participate. Patients who agree, will be randomized to either non-instrumented or instrumented arthrodesis group. Intra-operative, peri-operative, and post-operative data will be collected and compared. The investigators predict to get very similar clinical outcomes between the two groups, with possibly less complications from the non-instrumented group and definitely a reduction in cost compared to the instrumented group.
- Conditions
- Degenerative Spondylolisthesis, Spinal Stenosis
- Being tested
- instrumented spinal fusion with laminectomy, non-instrumented spinal fusion with laminectomy
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
instrumented spinal fusion with laminectomyProcedure or surgery
Once determined that a patient has single level "static" degenerative spondylolisthesis and is planning to schedule surgery the patient will be approached by a research team member explaining the study and reviewing the informed consent document. If the patient chooses to participate, he or she will be randomized to be apart of the non-instrumented arthrodesis with laminectomy group or the instrumented arthrodesis with laminectomy group. Both are standard approved surgical approaches; however, using instrumentation is the more commonly used approach.
non-instrumented spinal fusion with laminectomyProcedure or surgery
Once determined that a patient has single level "static" degenerative spondylolisthesis and is planning to schedule surgery the patient will be approached by a research team member explaining the study and reviewing the informed consent document. If the patient chooses to participate, he or she will be randomized to be apart of the non-instrumented arthrodesis with laminectomy group or the instrumented arthrodesis with laminectomy group. Both are standard approved surgical approaches; however, using instrumentation is the more commonly used approach.
| Study group | Role | What they receive |
|---|---|---|
| instrumented arthrodesis | Active comparator | Degenerative Spondylolisthesis and Spinal Stenosis patients having a surgical procedure. The surgical procedure is the intervention and is a spinal fusion with use of instrumentation and lumbar laminectomy. No additional "drug" or "device" intervention. Receives: Procedure: instrumented spinal fusion with laminectomy |
| non-instrumented arthrodesis | Active comparator | Degenerative Spondylolisthesis and Spinal Stenosis patients having a surgical procedure. The surgical procedure is the intervention and is a spinal fusion without the use of instrumentation and lumbar laminectomy. No additional "drug" or "device" intervention. Receives: Procedure: non-instrumented spinal fusion with laminectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Outcome Scores: SF-12/SF-36 Quality of Life Questionnaires
Measured by patient outcome survey such as the SF-12 or SF-36 Questionnaire (all questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible)
Measured: Up to 2 years
Functional Outcome Scores: Oswestry Disability Index (ODI) Questionnaire
Measured by patient outcome survey such as the Oswestry Disability Index (ODI) that assesses low back pain (scoring ranges from 0 to >35)
Measured: Up to 2 years
Secondary outcomes (5)
Rate of Infection
Wound Complications
Measured: Expected average of 4 weeks
Rate of Symptomatic Pseudoarthrosis
Measured: Up to 2 years
Need for Revision Surgery
Return to the OR
Measured: Up to 2 years
Length of Hospital Stay
Measured: Expected average of 1 week
Surgical Time
Measured: 2-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: The study did not receive IRB approval and was withdrawn
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.
- More trials run by University of PittsburghThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joon Yung Lee, MD, University of Pittsburgh
- Investigators
- Joon Y Lee, M.D., Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530775
- Sponsor's protocol ID
- PRO15040227
- Status last verified
- Dec 2015
- First submitted
- 18 Aug 2015
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Is Instrumentation Necessary for "Static" Degenerative Spondylolisthesis - A Prospective Randomized Clinical Study"
- ClinicalTrials.gov ID
- NCT02530775
- Acronym / sponsor ID
- PRO15040227
- Conditions
- Degenerative Spondylolisthesis, Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study did not receive IRB approval and was withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Aug 2015 (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.
The purpose of this study is to determine whether instrumented lumbar fusion provides superior clinical outcomes in comparison to non-instrumented fusion in patients with "static" degenerative spondylolisthesis.
Detailed description
This study will determine whether instrumented lumbar fusion will provide superior clinical outcomes in comparison to non-instrumented fusion in patients with "STATIC" degenerative spondylolisthesis. At the time of scheduling surgery, patients who meet the inclusion/exclusion criteria will be asked to participate. Patients who agree, will be randomized to either non-instrumented or instrumented arthrodesis group. Intra-operative, peri-operative, and post-operative data will be collected and compared. The investigators predict to get very similar clinical outcomes between the two groups, with possibly less complications from the non-instrumented group and definitely a reduction in cost compared to the instrumented group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| instrumented arthrodesis | Active comparator | Procedure: instrumented spinal fusion with laminectomyDegenerative Spondylolisthesis and Spinal Stenosis patients having a surgical procedure. The surgical procedure is the intervention and is a spinal fusion with use of instrumentation and lumbar laminectomy. No additional "drug" or "device" intervention. |
| non-instrumented arthrodesis | Active comparator | Procedure: non-instrumented spinal fusion with laminectomyDegenerative Spondylolisthesis and Spinal Stenosis patients having a surgical procedure. The surgical procedure is the intervention and is a spinal fusion without the use of instrumentation and lumbar laminectomy. No additional "drug" or "device" intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with stable L4-5 spondylolisthesis on lumbar flexion and extension radiographs. Stability will be determined by the treating physician.
- Patients with concomitant spinal stenosis.
- Laminectomy at any lumbar levels of stenosis.
- Fusion only at L4-5 level.
Key exclusion criteria (6 listed)
- Prior lumbar spine surgery
- Multi-level spondylolisthesis
- Anterior interbody work/fusion
- Tumor
- Infection
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 |
|---|---|---|
| instrumented spinal fusion with laminectomyOnce determined that a patient has single level "static" degenerative spondylolisthesis and is planning to schedule surgery the patient will be approached by a research team member explaining the study and reviewing the informed consent document. If the patient chooses to participate, he or she will be randomized to be apart of the non-instrumented arthrodesis with laminectomy group or the instrumented arthrodesis with laminectomy group. Both are standard approved surgical approaches; however, using instrumentation is the more commonly used approach. | Procedure or surgery | instrumented arthrodesis |
| non-instrumented spinal fusion with laminectomyOnce determined that a patient has single level "static" degenerative spondylolisthesis and is planning to schedule surgery the patient will be approached by a research team member explaining the study and reviewing the informed consent document. If the patient chooses to participate, he or she will be randomized to be apart of the non-instrumented arthrodesis with laminectomy group or the instrumented arthrodesis with laminectomy group. Both are standard approved surgical approaches; however, using instrumentation is the more commonly used approach. | Procedure or surgery | non-instrumented arthrodesis |
Primary outcome
Functional Outcome Scores: SF-12/SF-36 Quality of Life Questionnaires
Time frame: Up to 2 years
Measured by patient outcome survey such as the SF-12 or SF-36 Questionnaire (all questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible)
Functional Outcome Scores: Oswestry Disability Index (ODI) Questionnaire
Time frame: Up to 2 years
Measured by patient outcome survey such as the Oswestry Disability Index (ODI) that assesses low back pain (scoring ranges from 0 to >35)
5 secondary outcomes
Rate of Infection
Time frame: Expected average of 4 weeks
Rate of Symptomatic Pseudoarthrosis
Time frame: Up to 2 years
Need for Revision Surgery
Time frame: Up to 2 years
Length of Hospital Stay
Time frame: Expected average of 1 week
Surgical Time
Time frame: 2-4 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
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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.
Joon Y Lee, M.D. principal investigator
University of Pittsburgh Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing instrumented spinal fusion with laminectomy and non-instrumented spinal fusion with laminectomy in people with Degenerative Spondylolisthesis and Spinal Stenosis, run by University of Pittsburgh.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 16 Dec 2015. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Functional Outcome Scores: SF-12/SF-36 Quality of Life Questionnaires (time frame: Up to 2 years). 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 16 Dec 2015.