Skip to main content
OpenTrials
Completed

NCT Number: NCT02348645

Decompression vs. Fusion for Stable Degenerative Spondylolisthesis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spinal Stenosis Back Pain Bone Diseases Low Back Pain Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases Spondylolisthesis Spondylolysis Spondylosis

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • a clinical history of back, buttock and leg pain with walking or standing that is improved when lying, sitting or bending forward
  • a clinical history of leg symptoms that are greater than or equal to back symptoms with walking or standing, and
  • 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

Treatment and study plan

Spinal Fusion

Procedure

Spinal decompression

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Jan 28, 2015
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.