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The purpose of the study is to determine the proper use of lower back screws and rods (instrumentation) and bony fusion in subjects with one level of degenerative spinal narrowing (stenosis) compressing nerves to the legs with one spinal bone slipping forward on another (spondylolisthesis). There are two types of operations that surgeons perform for this problem. Some spinal surgeons remove some bone in the back (laminectomy) to decompress the nerves. Other surgeons perform a laminectomy (decompression) as above, but feel that it is also important to strengthen the back by placing screws and rods into the spine and adding more bone to obtain a new bridge of bone away from the nerves (decompression with instrumented fusion). This study aims to test the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long term patient outcomes.
There is considerable debate among spinal surgeons regarding the optimal surgical procedure for lumbar spinal stenosis with a grade I spondylolisthesis. The major question is whether or not instrumented pedicle screw fusion should be undertaken when a decompressive laminectomy is performed to relieve neural compression. This multi-center, randomized, prospective clinical study aims to address this question by testing the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long-term patient outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Lumbar Laminectomy without Fusion |
|
| 2 | Active Comparator | Lumbar Laminectomy with Pedicle Screw Instrumented Fusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar Laminectomy with Instrumented Pedicle Screw Fusion | Procedure | Removal of bone to decompress spinal nerves with placement of spinal screws and extra bone to strengthen the spine |
| Measure | Description | Time Frame |
|---|---|---|
| SF-36 (physical component summary score) | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index | 2 year, 3 year, 4 year | |
| Major Complication rate | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zoher Ghogawala, MD | Yale University School of Medicine (Greenwich Hospital) | Study Director |
| Edward C Benzel, MD | Cleveland Clinic Spine Institute (Cleveland Clinic Foundation) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greenwich Hospital | Greenwich | Connecticut | 06830 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15478364 | Background | Ghogawala Z, Benzel EC, Amin-Hanjani S, Barker FG 2nd, Harrington JF, Magge SN, Strugar J, Coumans JV, Borges LF. Prospective outcomes evaluation after decompression with or without instrumented fusion for lumbar stenosis and degenerative Grade I spondylolisthesis. J Neurosurg Spine. 2004 Oct;1(3):267-72. doi: 10.3171/spi.2004.1.3.0267. | |
| 9431616 |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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| Lumbar Laminectomy | Procedure | Removal of bone to decompress spinal nerves |
|
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| Cleveland Clinic Spine Institute | Cleveland | Ohio | 44195 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Fischgrund JS, Mackay M, Herkowitz HN, Brower R, Montgomery DM, Kurz LT. 1997 Volvo Award winner in clinical studies. Degenerative lumbar spondylolisthesis with spinal stenosis: a prospective, randomized study comparing decompressive laminectomy and arthrodesis with and without spinal instrumentation. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2807-12. doi: 10.1097/00007632-199712150-00003. |
| 2071615 | Background | Herkowitz HN, Kurz LT. Degenerative lumbar spondylolisthesis with spinal stenosis. A prospective study comparing decompression with decompression and intertransverse process arthrodesis. J Bone Joint Surg Am. 1991 Jul;73(6):802-8. |
| 27074067 | Derived | Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, Coumans JV, Harrington JF, Amin-Hanjani S, Schwartz JS, Sonntag VK, Barker FG 2nd, Benzel EC. Laminectomy plus Fusion versus Laminectomy Alone for Lumbar Spondylolisthesis. N Engl J Med. 2016 Apr 14;374(15):1424-34. doi: 10.1056/NEJMoa1508788. |
| 26501698 | Derived | Ghogawala Z, Schwartz JS, Benzel EC, Magge SN, Coumans JV, Harrington JF, Gelbs JC, Whitmore RG, Butler WE, Barker FG 2nd. Increased Patient Enrollment to a Randomized Surgical Trial Through Equipoise Polling of an Expert Surgeon Panel. Ann Surg. 2016 Jul;264(1):81-6. doi: 10.1097/SLA.0000000000001483. |
| 23373567 | Derived | Blumenthal C, Curran J, Benzel EC, Potter R, Magge SN, Harrington JF Jr, Coumans JV, Ghogawala Z. Radiographic predictors of delayed instability following decompression without fusion for degenerative grade I lumbar spondylolisthesis. J Neurosurg Spine. 2013 Apr;18(4):340-6. doi: 10.3171/2013.1.SPINE12537. Epub 2013 Feb 1. |
| D055009 |
| Spondylosis |