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Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis (I-Spondy)

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
Sponsor:
Information provided by (Responsible Party):
AOSpine North America Research Network

Tracking Information
First Submitted Date September 29, 2015
First Posted Date October 1, 2015
Last Update Posted Date May 21, 2021
Actual Study Start Date March 2016
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 29, 2015)
Change in Oswestry Disability Index Score v2.1a [ Time Frame: between pre-operative and 730 days (24 months) ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 29, 2015)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis
Official Title A Multi-Center, Prospective, Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Isthmic spondylolisthesis (IS)
Condition Isthmic Spondylolisthesis
Intervention
  • Procedure: Anterior Lumbar Interbody Fusion (ALIF)
  • Procedure: Posterior Fusion
    • Posterolateral Fusion (PLF)
    • Posterior Lumbar Interbody Fusion (PLIF)
    • Transforaminal Lumbar Interbody Fusion (TLIF)
Study Groups/Cohorts
  • anterior cohort
    Anterior Lumbar Interbody Fusion (ALIF)
    Intervention: Procedure: Anterior Lumbar Interbody Fusion (ALIF)
  • posterior cohort
    • Posterolateral Fusion (PLF)
    • Posterior Lumbar Interbody Fusion (PLIF)
    • Transforaminal Lumbar Interbody Fusion (TLIF)
    Intervention: Procedure: Posterior Fusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: September 29, 2015)
180
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2023
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02564705
Other Study ID Numbers SPN-14-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party AOSpine North America Research Network
Original Responsible Party Same as current
Current Study Sponsor AOSpine North America Research Network
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account AOSpine North America Research Network
Verification Date May 2021