Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis (I-Spondy)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02564705 |
Recruitment Status :
Active, not recruiting
First Posted : October 1, 2015
Last Update Posted : May 21, 2021
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Condition or disease | Intervention/treatment |
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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 |
Actual Study Start Date : | March 2016 |
Estimated Primary Completion Date : | April 2023 |
Estimated Study Completion Date : | April 2023 |
Group/Cohort | Intervention/treatment |
---|---|
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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- Change in Oswestry Disability Index Score v2.1a [ Time Frame: between pre-operative and 730 days (24 months) ]
- 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 |
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

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
United States, California | |
University of California San Francisco | |
San Francisco, California, United States, 94143-0122 | |
United States, Illinois | |
Carle Foundation Hospital | |
Urbana, Illinois, United States, 61801 | |
United States, Kansas | |
Kansas University Medical Center | |
Kansas City, Kansas, United States, 66160 | |
United States, Maryland | |
University of Maryland Medical Center | |
Baltimore, Maryland, United States, 21201 | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21287 | |
United States, Missouri | |
University of Missouri | |
Columbia, Missouri, United States, 65212 | |
Washington University | |
Saint Louis, Missouri, United States, 63110 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Thomas Jefferson University / Rothman Institute | |
Philadelphia, Pennsylvania, United States, 19107 | |
Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Utah | |
University of Utah Department of Orthopedics | |
Salt Lake City, Utah, United States, 84108 | |
United States, Virginia | |
University of Virginia Department of Neurosurgery | |
Charlottesville, Virginia, United States, 22908 | |
United States, Washington | |
Swedish Medical Center | |
Seattle, Washington, United States, 98122 | |
Canada, Ontario | |
Toronto Western Hospital | |
Toronto, Ontario, Canada, M5T 2S8 |
Responsible Party: | AOSpine North America Research Network |
ClinicalTrials.gov Identifier: | NCT02564705 |
Other Study ID Numbers: |
SPN-14-001 |
First Posted: | October 1, 2015 Key Record Dates |
Last Update Posted: | May 21, 2021 |
Last Verified: | May 2021 |
Spondylolisthesis Spondylolysis Spondylosis |
Spinal Diseases Bone Diseases Musculoskeletal Diseases |