Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decompression with fusion | Active Comparator | Spinal decompression surgery with instrumented spinal fusion |
|
| Decompression alone | Active Comparator | Midline-sparing spinal decompression alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal fusion | Procedure |
| ||
| Spinal decompression |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients recruited | 1 year | |
| Number of eligible patients | 1 year | |
| Reasons for refusal to consent | 1 year | |
| Proportion of patients who adhere to randomized allocation | 2 years | |
| Number of patients refusing to consent due to blinding | 1 year | |
| Blinding status | Patient's assessment of which treatment they received | 1.5 months post-surgery |
| Oswestry Disability Index (ODI) | 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. | 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery |
| Proportion of patients who receive randomized allocation | 2 years | |
| Number of patients refusing to consent due to randomization | 1 year | |
| Number, type and severity of adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| Short-Form 12 scores: Physical Function, Bodily Pain, Physical Component Summary | 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. |
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yoga Raja Rampersaud, MD FRCSC | University Health Network, Toronto | Principal Investigator |
| Anthony Perruccio, PhD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Calgary | Alberta | T2N 2N9 | Canada | ||
| Mackenzie Health Sciences Centre |
Not provided
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D013168 | Spondylolisthesis |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
Not provided
Not provided
| ID | Term |
|---|---|
| D013123 | Spinal Fusion |
| D007796 | Laminectomy |
| ID | Term |
|---|---|
| D001174 | Arthrodesis |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| End of hospital stay (average 6.5 days post-surgery) |
| Baseline; 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery |
| Euro-QoL health utility index | 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). | Baseline; 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery |
| Patient Health Questionnaire-9 score | 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. | Baseline |
| Costs incurred by patients | monthly from 1.5 to 12 months post-surgery; 24 months post-surgery |
| Hospital cost | End of hospital stay (average 6.5 days post-surgery) |
| Healthcare services used | Other Ontario Health Insurance Plan (OHIP)-billed services used | Referral to 1 year post-surgery |
| Edmonton |
| Alberta |
| T6G 2B7 |
| Canada |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| London Health Sciences Centre - Victoria Hospital | London | Ontario | N6A 5W9 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| University Health Network | Toronto | Ontario | M5T 2S8 | Canada |
| Montreal General Hospital | Montreal | Quebec | H3G 1A4 | Canada |
| D055009 |
| Spondylosis |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019299 |
| Decompression, Surgical |
| D019635 | Neurosurgical Procedures |