Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis (I-Spondy)
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| ClinicalTrials.gov Identifier: NCT02564705 |
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Recruitment Status :
Recruiting
First Posted : October 1, 2015
Last Update Posted : April 17, 2018
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Sponsor:
AOSpine North America Research Network
Information provided by (Responsible Party):
AOSpine North America Research Network
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Brief Summary:
The aim of this study is to compare outcomes and cost-effectiveness of anterior versus posterior surgical treatment for lumbar Isthmic Spondylolisthesis. The primary objective is to compare treatment effectiveness in terms of functional outcomes as measured by Oswestry Disability Index (ODI) v2.1a and to compare safety outcomes measured by treatment-related adverse events. Secondary objectives are to compare treatments in terms of differences in pain, quality of life, health utilities, and need for re-operation. Finally, a cost-effectiveness analysis will be performed. This analysis will take the form of cost-effectiveness if there is a difference in treatment effects or cost-minimization if there is no difference in treatment efficacy.
| Condition or disease | Intervention/treatment |
|---|---|
| Isthmic Spondylolisthesis | Procedure: Anterior Lumbar Interbody Fusion (ALIF) Procedure: Posterior Fusion |
| Study Type : | Observational |
| Estimated Enrollment : | 180 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | A Multi-Center, Prospective, Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis |
| Study Start Date : | February 2016 |
| Estimated Primary Completion Date : | May 2019 |
| Estimated Study Completion Date : | May 2019 |
| Group/Cohort | Intervention/treatment |
|---|---|
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anterior cohort
Anterior Lumbar Interbody Fusion (ALIF)
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Procedure: Anterior Lumbar Interbody Fusion (ALIF) |
posterior cohort
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Procedure: Posterior Fusion
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Primary Outcome Measures :
- Change in Oswestry Disability Index Score v2.1a [ Time Frame: between pre-operative and 730 days (24 months) ]
Secondary Outcome Measures :
- Change in Numeric Pain Rating Scale (Pain NRS) for low back pain [ Time Frame: between pre-operative and 730 days (24 months) ]
- Change in EQ-5D-3L health utility index [ Time Frame: between pre-operative and 730 days ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with Isthmic spondylolisthesis (IS)
Criteria
Inclusion Criteria:
- Aged 18 to 80 years, inclusive
- Grade I, II or III (less than 75% slip of the cephalad vertebra compared to the caudal vertebra) isthmic spondylolisthesis at single level between L4 and S1
- Unresponsive to a minimum of 3 months of non-surgical treatment
- No previous surgical treatment for isthmic spondylolisthesis
- Patients who are medically suitable for surgical management
- Patients who have consented for surgical treatment
- Willing and able to comply with the Investigational Protocol (IP)
- Informed Consent Form (ICF) signed by patient
Exclusion Criteria:
- Any previous lumbar spine surgery
- Patient has significant scoliosis (Cobb angle is greater than 25 degrees)
- Subject has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction
- Subject is pregnant or of child-bearing potential and not currently on adequate birth control method
- Active infection at the surgical site
- Recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation, in the opinion of the Investigator
- Pre-existent neurologic or mental disorder which would preclude accurate evaluation and follow-up (i.e. Alzheimer's disease, Parkinson's disease, unstable psychiatric disorder with hallucinations and/or delusions or schizophrenia
- Participation in another clinical trial of drug or device within the past 30 days that could influence the outcomes of this study
- Is a prisoner
- Acquired immune deficiency syndrome (AIDS) or AIDS-related complex
- Active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated; patients with carcinoma in situ of the uterine cervix treated definitely more than 1 year prior to enrollment may enter the study
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): NCT02564705
Contacts
| Contact: Paul Arnold, MD | (913) 588-7587 | parnold@kumc.edu | |
| Contact: Branko Kopjar, MD PhD | (206) 607-6861 | branko.kopjar@nor-consult.com |
Locations
| United States, California | |
| University of California San Francisco | Terminated |
| San Francisco, California, United States, 94143-0122 | |
| United States, Kansas | |
| Kansas University Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Contact: Paul Arnold, MD 913-558-7587 parnold@kumc.edu | |
| Contact: Linda Jianas (913) 558-3252 ljianas@kumc.edu | |
| Principal Investigator: Paul Arnold, MD | |
| United States, Maryland | |
| University of Maryland Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Steven Ludwig, MD 410-328-8808 sludwig@umoa.umm.edu | |
| Contact: Alysa Nash (410) 328-8808 ANash@umoa.umm.edu | |
| Principal Investigator: Steven Ludwig, MD | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Daniel Sciubba, MD 410-955-4424 dsciubb1@jhmi.edu | |
| Contact: Zach Pennington (410) 995-4424 zpennin1@jhmi.edu | |
| Principal Investigator: Daniel Sciubba, MD | |
| United States, Missouri | |
| University of Missouri | Terminated |
| Columbia, Missouri, United States, 65212 | |
| Washington University | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: W. Zack Ray, MD 314-362-9959 rayz@wudosis.wustl.edu | |
| Contact: Aubrey Wright 314-362-3114 wrightau@wudosis.wustl.edu | |
| Principal Investigator: W. Zack Ray, MD | |
| United States, Ohio | |
| Cleveland Clinic | Active, not recruiting |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Thomas Jefferson University / Rothman Institute | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Alexander R. Vaccaro, MD, PhD 267-339-3578 Alex.Vaccaro@rothmaninstitute.com | |
| Contact: Shoshana Fishbein (484) 433-7878 Shoshana.Fishbein@rothmaninstitute.com | |
| Thomas Jefferson University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: James Harrop, MD 215-955-7000 james.harrop@jefferson.edu | |
| Contact: Maria Patino (215) 955-2245 maria.patino@jefferson.edu | |
| Principal Investigator: James Harrop, MD | |
| United States, Utah | |
| University of Utah Department of Orthopedics | Recruiting |
| Salt Lake City, Utah, United States, 84108 | |
| Contact: Darrel Brodke, MD 801-587-5450 darrel.brodke@hsc.utah.edu | |
| Contact: Ashley Neese (801) 587-5430 Ashley.Neese@hsc.utah.edu | |
| Principal Investigator: Darrel Brodke, MD | |
| United States, Virginia | |
| University of Virginia Department of Neurosurgery | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Christopher Shaffrey, MD 434-243-9728 CIS8Z@hscmail.mcc.virginia.edu | |
| Contact: Judy Beenhakker (434) 982-1856 jgb3p@virginia.edu | |
| Principal Investigator: Christopher Shaffrey, MD | |
| United States, Washington | |
| Swedish Medical Center | Recruiting |
| Seattle, Washington, United States, 98122 | |
| Contact: Jens Chapman, MD 206-731-3466 Jens.Chapman@swedish.org | |
| Contact: Cheryl Kelly (206) 320-2334 cheryl.kelly@swedish.org | |
| Principal Investigator: Jens Chapman | |
| Canada, Ontario | |
| Toronto Western Hospital | Recruiting |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Contact: Michael Fehlings, MD, PhD (416) 603-5627 Michael.Fehlings@uhn.on.ca | |
| Contact: Yuriy Petrenko (416) 603-5285 yuriy.petrenko@uhn.on.ca | |
| Principal Investigator: Michael Fehlings, MD, PhD | |
Sponsors and Collaborators
AOSpine North America Research Network
| Responsible Party: | AOSpine North America Research Network |
| ClinicalTrials.gov Identifier: | NCT02564705 History of Changes |
| Other Study ID Numbers: |
SPN-14-001 |
| First Posted: | October 1, 2015 Key Record Dates |
| Last Update Posted: | April 17, 2018 |
| Last Verified: | April 2018 |
Additional relevant MeSH terms:
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Spondylolisthesis Spondylolysis Spondylosis |
Spinal Diseases Bone Diseases Musculoskeletal Diseases |