Patients With Spinal Stenosis Indicated for LLIF Clinical Trial
— IDVDOfficial title:
Is Indirect Decompression Sufficient for the Treatment of Central Stenosis?: A Randomized Controlled Trial
| Verified date | October 2021 |
| Source | Hospital for Special Surgery, New York |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a prospective, randomized clinical trial of patients undergoing 1-level lateral lumbar spinal fusion. This study seeks to randomize patients indicated for Lateral Lumbar Interbody Fusion (LLIF) into one of two groups: direct decompression and indirect decompression.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | September 29, 2021 |
| Est. primary completion date | September 29, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Fusion indicated by the treating surgeon. Fusion may be indicated for one or more of the following reasons: - Mobile degenerative spondylolisthesis - Severe vertical foraminal stenosis - Adjacent segment degeneration and/or degenerative disc disease with suspected discogenic pain - One-level central canal stenosis - WITH neurogenic claudication - As measured in preoperative MRI - Oswestry Low Back Pain Disability Questionnaire score > 35% (18/50) - Failed 3 months of conservative treatment - Willing to give written informed consent and psychosocially, mentally, and physically able to comply fully with protocol, including adhering to follow-up schedule and requirements, and filling out forms Exclusion Criteria: - Multilevel central canal stenosis - Patients with vertebral endplate dimensions that are too small to allow for safe placement of an intervertebral cage - Known allergy to titanium, polyethylene, cobalt, chromium, or molybdenum - Prior surgery at index disc level (discectomy, decompression, or fusion) - History of spinal or vertebral infection of the lumbar spine - History of vertebral fracture of the lumbar spine - Current pregnancy or interest in becoming pregnant over the next 1 year - Active infection-systemic or local - Non-English speakers |
| Country | Name | City | State |
|---|---|---|---|
| United States | Hospital for Special Surgery | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital for Special Surgery, New York |
United States,
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* Note: There are 19 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Oswestry Disability Index (ODI) | Change in Oswestry Disability Index (ODI) 100 point scale. The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools [1].
For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated by adding all scores for each statement, divided by 50 total possible points, and then multiplied by 100 for a percentage. Percentage scores are interpreted on a scale from 0-20% as minimal disability to 61-100% as crippled. |
Up to 12 months post-operatively | |
| Primary | Comparison of Oswestry Disability Index (ODI) | Compare ODI scores to assess the kinetics of improvement in the control (direct decompression) vs. treatment (indirect decompression) groups.
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools [1]. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated by adding all scores for each statement, divided by 50 total possible points, and then multiplied by 100 for a percentage. Percentage scores are interpreted on a scale from 0-20% as minimal disability to 61-100% as crippled. |
Up to 24 months post-operatively. (6 weeks, 3, 6, 12, and 24 months timepoints) | |
| Secondary | Reoperation Rate | Reoperation rate on the lumbar spine within 12 months and within 24 months | Within 12 months and 24 months, post-operatively. | |
| Secondary | Complication Rate | Complication rate within 12 months and within 24 months | Within 12 months and 24 months, post-operatively. | |
| Secondary | Numeric Rated Scale (NRS)-Back and Leg pain | Patient Reported Outcomes: Numeric Rated Scale (NRS)-back and leg pain scores | 6- Weeks, 3-, 6-, 12-, and 24-Months. | |
| Secondary | Radiographic Measurements - Lumbar Lordosis | Radiographic measurements at 12 months will be compared to preoperative measurements to quantify the change in lumbar lordosis as a result of Lateral Lumbar Interbody Fusion (LLIF). Measurements will be taken in millimeters by (2) co-investigators. | Preoperative and 12-Month radiographs | |
| Secondary | Radiographic Measurements - Segmental Lordosis | Radiographic measurements at 12 months will be compared to preoperative measurements to quantify the change in segmental lordosis as a result of Lateral Lumbar Interbody Fusion (LLIF). Measurements will be taken in millimeters by (2) co-investigators. | Preoperative and 12-Month radiographs | |
| Secondary | Radiographic Measurements - Disc Space Height | Radiographic measurements at 12 months will be compared to preoperative measurements to quantify the change in disc space height as a result of Lateral Lumbar Interbody Fusion (LLIF). Measurements will be taken in millimeters by (2) co-investigators. | Preoperative and 12-Month radiographs |