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Decompression vs. Fusion for Stable Degenerative Spondylolisthesis

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02348645
Recruitment Status : Recruiting
First Posted : January 28, 2015
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

The purpose of this study is to assess the feasibility of a full-scale multicenter randomized, controlled trial comparing the effectiveness of two surgical treatments for a condition associated with lumbar spinal stenosis called degenerative lumbar spondylolisthesis. Both treatments are currently used, but individual surgeons use different selection criteria for each treatment and use the procedures at different rates. The two procedures are decompression with fusion (the most common surgical procedure for spondylolisthesis) and midline-sparing decompression alone (which is also a standard treatment, but is not as widely used for treating spondylolisthesis). The investigators plan to collect the evidence on the following:

  1. The feasibility of the trial protocol, and
  2. Preliminary data on the effectiveness of each treatment.

Condition or disease Intervention/treatment Phase
Spinal Stenosis Spondylolisthesis Procedure: Spinal fusion Procedure: Spinal decompression Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Decompression Alone vs. Decompression and Instrumented Fusion for the Management of Lumbar Spinal Stenosis Associated With Stable Degenerative Spondylolisthesis: A Pragmatic Randomized Clinical Pilot Trial
Study Start Date : October 2014
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
Active Comparator: Decompression with fusion
Spinal decompression surgery with instrumented spinal fusion
Procedure: Spinal fusion
Procedure: Spinal decompression
Active Comparator: Decompression alone
Midline-sparing spinal decompression alone
Procedure: Spinal decompression



Primary Outcome Measures :
  1. Number of patients recruited [ Time Frame: 1 year ]
  2. Number of eligible patients [ Time Frame: 1 year ]
  3. Reasons for refusal to consent [ Time Frame: 1 year ]
  4. Proportion of patients who adhere to randomized allocation [ Time Frame: 2 years ]
  5. Number of patients refusing to consent due to blinding [ Time Frame: 1 year ]
  6. Blinding status [ Time Frame: 1.5 months post-surgery ]
    Patient's assessment of which treatment they received

  7. Oswestry Disability Index (ODI) [ Time Frame: 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery ]
    10-item patient-reported questionnaire measuring disability related to low back pain. Each item has six response options ranging from 0 to 5; the responses are summed and rescaled so 0 indicates no disability and 100 indicates extreme disability.

  8. Proportion of patients who receive randomized allocation [ Time Frame: 2 years ]
  9. Number of patients refusing to consent due to randomization [ Time Frame: 1 year ]
  10. Number, type and severity of adverse events [ Time Frame: End of hospital stay (average 6.5 days post-surgery) ]

Secondary Outcome Measures :
  1. Short-Form 12 scores: Physical Function, Bodily Pain, Physical Component Summary [ Time Frame: Baseline; 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery ]
    12-item patient-reported questionnaire for general health status based on the SF-36 Health Survey (version 2). Measures eight health domains, each scored so 0 is the worst and 100 is the best possible score: general health (GH), physical function (PF), bodily pain (BP), role limitations due to physical problems (RP), role limitations due to emotional problems (RE), mental health (MH), social functioning (SF), and energy/fatigue (VT). The domain scores can be aggregated into Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, also scaled so 0 is the worst and 100 is the best possible score. This study will focus primarily on the Physical Function domain, the Bodily Pain domain, and the Physical Component Summary score.

  2. Euro-QoL health utility index [ Time Frame: Baseline; 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery ]
    Patient-reported questionnaire for general health state which includes five items (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a visual analog scale for self-rated health state. Using an existing U.S. population-based value set, responses will be converted to the corresponding health utility index (1.0=perfect health and 0.0=death).

  3. Patient Health Questionnaire-9 score [ Time Frame: Baseline ]
    Patient-reported questionnaire that measures severity of depression symptoms. It is scored from 0 to 27, with the following interpretation: 0-4=no symptoms, 5-9=minimal symptoms; 10-14=mild/minor depression or dysthymia; 15-19=moderate major depression; 20-27=severe major depression.

  4. Costs incurred by patients [ Time Frame: monthly from 1.5 to 12 months post-surgery; 24 months post-surgery ]
  5. Hospital cost [ Time Frame: End of hospital stay (average 6.5 days post-surgery) ]
  6. Healthcare services used [ Time Frame: Referral to 1 year post-surgery ]
    Other Ontario Health Insurance Plan (OHIP)-billed services used



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients deemed to be surgical candidates with focal (1-2 level) lumbar spinal stenosis (LSS) and associated stable degenerative spondylolisthesis with the following characteristics:

    1. a clinical history of back, buttock and leg pain with walking or standing that is improved when lying, sitting or bending forward
    2. a clinical history of leg symptoms that are greater than or equal to back symptoms with walking or standing, and
    3. greater than 6 months of symptoms with failed conservative care
  • aged 50 or over
  • sufficient fluency in English or French to provide informed consent and complete questionnaires with or without the need of an interpreter

Exclusion Criteria:

  • Greater than 25% listhesis or spinal instability as demonstrated by motion (>5mm of translation) on flexion extension radiographs or non-loaded (MRI/CT or supine x-rays) to loaded imaging (standing radiograph)
  • Presence of kyphosis (>0 degrees at the affected level or globally), degenerative scoliosis (>10 degree using the Cobb method) with rotatory or lateral listhesis on preoperative x-rays
  • Clinical history of osteoporotic fracture or chronic oral steroid use
  • Previous posterior lumbar spinal surgery (excluding prior microdiscectomy)
  • Patients who have evidence of neurological disorders that affect physical function (e.g. peripheral neuropathy), neuromuscular disorders (e.g. multiple sclerosis, Parkinson's etc.) or systemic illness (e.g. inflammatory arthritis) that affects physical function

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): NCT02348645


Contacts
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Contact: Yoga Raja Rampersaud, MD FRCSC (416) 603-5800 ext 5252 raja.rampersaud@uhn.ca

Locations
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Canada, Alberta
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N 2N9
Contact: R J Hurlbert, MD FRCSC       jhurlber@ucalgary.ca   
Principal Investigator: R J Hurlbert, MD FRCSC         
Mackenzie Health Sciences Centre Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Richard Fox, MD MSc FRCSC    780 407 6324    Richard.Fox@albertahealthservices.ca   
Principal Investigator: Richard Fox, MD MSc FRCSC         
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Charles Fisher, MD FRCSC       charles.fisher@vch.ca   
Principal Investigator: Charles Fisher, MD FRCSC         
Principal Investigator: Nicolas Dae, MD FRCSC         
Canada, New Brunswick
Horizon Health Network Withdrawn
Saint John, New Brunswick, Canada, E2K 4X2
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Sean Christie, MD FRCSC       sean.christie@dal.ca   
Principal Investigator: Sean Christie, MD FRCSC         
Principal Investigator: William M Oxner, MD FRCSC         
Principal Investigator: Andrew Glennie, MD FRCSC         
Canada, Ontario
Hamilton General Hospital Withdrawn
Hamilton, Ontario, Canada, L8L 2X2
London Health Sciences Centre - Victoria Hospital Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Christopher Bailey, MD FRCSC    (519) 685-8500    chris.bailey@lhsc.on.ca   
Principal Investigator: Christopher Bailey, MD FRCSC         
The Ottawa Hospital - Civic Campus Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Eugene Wai, MD FRCSC       ewai@ottawahospital.on.ca   
Principal Investigator: Eugene Wai, MD FRCSC         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Albert Yee, MD FRCSC       albert.yee@sunnybrook.ca   
Principal Investigator: Albert Yee, MD MSc FRCSC         
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Henry Ahn, MD FRCSC    (416) 864-6005    ahnh@smh.ca   
Principal Investigator: Henry Ahn, MD FRCSC         
University Health Network Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Yoga Raja Rampersaud, MD FRCSC       raja.rampersaud@uhn.ca   
Principal Investigator: Yoga Raja Rampersaud, MD FRCSC         
Principal Investigator: Anthony Perruccio, PhD         
Principal Investigator: Peter C Coyte, PhD         
Principal Investigator: Aileen Davis, PhD         
Canada, Quebec
Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Peter Jarzem, MD FRCSC       pjarzem@videotron.ca   
Principal Investigator: Peter Jarzem, MD FRCSC         
Canada, Saskatchewan
Regina General Hospital Not yet recruiting
Regina, Saskatchewan, Canada, S4P 0W5
Contact: Alan Beggs, MD       alanbeggs@sasktel.net   
Principal Investigator: Alan Beggs, MD FRCSC         
Royal University Hospital Withdrawn
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Yoga Raja Rampersaud, MD FRCSC University Health Network, Toronto
Principal Investigator: Anthony Perruccio, PhD University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02348645    
Other Study ID Numbers: 13-6927-B
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Keywords provided by University Health Network, Toronto:
Pilot projects
Feasibility studies
Intervention studies
Orthopedics
Orthopedic Procedures
Neurosurgical Procedures
Neurosurgery
Spine
Spinal Fusion
Spondylodesis
Spondylosyndesis
Laminectomy
Foraminotomy
Decompression, surgical
Low Back Pain
Quality of Life
Additional relevant MeSH terms:
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Spinal Stenosis
Spondylolisthesis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis