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Degenerative spondylolisthesis describes the slip of one spinal segment relative to the adjacent segment. It is usually associated with spinal stenosis (which limits one's ability to walk and stand) and is the most common indication for surgery in adults over age 65 years. A variety of surgical techniques are available; the most common are the Posterolateral Instrumented Fusion (PLF), and Interbody Fusion (IF) including Posterolateral Interbody Fusion (PLIF), and Transforaminal Interbody fusion (TLIF). IF uses a cage that is placed within the cleaned out disc space between the vertebral bodies being fused. Although this approach achieves a good fusion rate and deformity correction it is associated with a higher surgical cost and potential intra-operative complication rate. What is more, no consensus exists as to whether IF provides better patient rated functional outcome and quality of life. If the advantages of IF do not translate into superior patient rated outcomes, then the risk-benefit ratio would be tipped in favor of PLF. The purpose of this study is to determine if IF is equivalent to PLF for the treatment of degenerative spondylolisthesis. The investigators will conduct a prospective randomized control trial comparing these two procedures. Our primary outcome measure will be the Oswestry Disability Index, which evaluates spinal pain and function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interbody Fusion | Active Comparator |
| |
| Posterolateral Fusion | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interbody Fusion | Procedure | The interbody fusion (IF) procedure requires exposure and removal of the disc, curetting the end plates, inserting a cage filled with bone graft, as well as stabilization with rods and screws. |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index | The Oswestry Disability Index is an effective method of measuring disability in patients with back and leg pain and is well suited to patients who have had persistent severe disability. It is a commonly utilized, validated, and highly reproducible. The questionnaire can be completed in less than 5 minutes and a large amount of normative data exists. | 1 year post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index | The Oswestry Disability Index is an effective method of measuring disability in patients with back and leg pain and is well suited to patients who have had persistent severe disability. It is a commonly utilized, validated, and highly reproducible. The questionnaire can be completed in less than 5 minutes and a large amount of normative data exists. | Enrollment, and at 6 weeks, 3 months, 6 months, 2 years, 5 years and post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale for back pain intensity (0-10: 0= no pain, 10=worst pain) | Enrollment at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery | |
| Visual Analogue Scale for leg pain intensity (0-10: 0= no pain, 10=worst pain) | Enrollment and at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher S Bailey, MD | Contact | 519-685-8500 | 55358 | Chris.Bailey@lhsc.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Christopher S Bailey, MD | The London Spine Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | Recruiting | London | Ontario | N6G 5L7 | Canada |
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|
| Posterolateral Fusion | Procedure | In posterolateral fusion stabilization is achieved using pedicle screws joined by rods. The graft used to facilitate fusion is placed between decorticated transverse processes and can be an autograft of iliac bone or local bone, allograft, or a synthetic expander. |
|
| SF-12 (General Health outcome measure) | The SF-12 is a standardized health related quality of life outcome questionnaire, which assess 8 health domains. The physical and mental component can be derived. It has been shown to be valid and reliable when applied to the spine patient population. | Enrollment at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery |
| Patient satisfaction | "All things considered, how satisfied are you with the results of your recent treatment for your spine fracture? 1-7, 8= not sure." This sentence is the recommended tool for assessing global satisfaction. | Enrollment and at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery |
| Cost analysis | Prolo economic score and cost analysis for each procedure | Enrollment, and at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery |
| Fusion rates | 6 months, 1 year, 5 year |
| Intra-operative Complication rate | within 6 weeks after sugery |
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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