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"Is Instrumentation Necessary for "Static" Degenerative Spondylolisthesis"

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ClinicalTrials.gov Identifier: NCT02530775
Recruitment Status : Withdrawn (The study did not receive IRB approval and was withdrawn)
First Posted : August 21, 2015
Last Update Posted : December 16, 2015
Sponsor:
Information provided by (Responsible Party):
Joon Yung Lee, MD, University of Pittsburgh

Brief 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.

Condition or disease Intervention/treatment Phase
Degenerative Spondylolisthesis Spinal Stenosis Procedure: instrumented spinal fusion with laminectomy Procedure: non-instrumented spinal fusion with laminectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "Is Instrumentation Necessary for "Static" Degenerative Spondylolisthesis - A Prospective Randomized Clinical Study"
Study Start Date : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
Active Comparator: instrumented arthrodesis
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.
Procedure: instrumented spinal fusion with laminectomy
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.

Active Comparator: non-instrumented arthrodesis
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.
Procedure: non-instrumented spinal fusion with laminectomy
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.




Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  1. Rate of Infection [ Time Frame: Expected average of 4 weeks ]
    Wound Complications

  2. Rate of Symptomatic Pseudoarthrosis [ Time Frame: Up to 2 years ]
  3. Need for Revision Surgery [ Time Frame: Up to 2 years ]
    Return to the OR

  4. Length of Hospital Stay [ Time Frame: Expected average of 1 week ]
  5. Surgical Time [ Time Frame: 2-4 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with stable L4-5 spondylolisthesis on lumbar flexion and extension radiographs. Stability will be determined by the treating physician.
  2. Patients with concomitant spinal stenosis.
  3. Laminectomy at any lumbar levels of stenosis.
  4. Fusion only at L4-5 level.

Exclusion Criteria:

  1. Prior lumbar spine surgery
  2. Multi-level spondylolisthesis
  3. Anterior interbody work/fusion
  4. Tumor
  5. Infection
  6. Trauma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530775


Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Joon Y Lee, M.D. University of Pittsburgh Medical Center

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Responsible Party: Joon Yung Lee, MD, M.D., University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02530775     History of Changes
Other Study ID Numbers: PRO15040227
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Spinal Stenosis
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis