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The purpose of this study is to evaluate the clinical performance of a decompression using the FDA cleared iO-Flex® System on-label in treating patients with spinal stenosis and stable grade I degenerative lumbar spondylolisthesis using a precision estimate assuming a 55% positive response rate.
This is a prospective, non-randomized, multi-center (up to 30 sites) controlled clinical study enrolling 100 subjects following a pre-specified protocol with no site enrolling more than 30 subjects. All eligible subjects providing written informed consent and meeting study eligibility criteria will receive a facet preserving decompression using the FDA cleared iO-Flex® system on label. Treatment success using the iO-Flex® System will be analyzed using a precision estimate assuming a 55% positive response rate.
In addition to baseline characteristics and procedural parameters, subject outcomes will be assessed at 6 weeks, 6-, 12-, and 24 months. The study will have an extended follow-up phase with annual follow-up contact through 5 years to evaluate retreatment for the original indication at these late time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery | Experimental | Decompression using the iO-Flex® system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decompression using the iO-Flex® system | Procedure | Decompression using the iO-Flex® system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index (ODI) | Responder analysis | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Operative success | Achieving intended decompression using the iO-Flex® System. The number of neural foramen in which the iO-Flex® System was used for decompression compared to the number in which an attempt was made but not completed. | Operative (day 1) |
| Oswestry Disability Index (ODI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvain Palmer, M.D. | Neurological Surgery Medical Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eden Medical Center | Castro Valley | California | 94546 | United States | ||
| Olympia Medical Center |
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Responder analysis |
| 6, 12, 36, 48 and 60 months |
| Oswestry Disability Index (ODI) | Comparison of ODI scores between baseline and each of the following follow-up visits: 6, 12, 24, 36, 48, and 60 month visits | 6, 12, 24, 36, 48 and 60 months |
| Numerical Rating Scale (NRS) | Comparison of NRS scores for back and leg pain between baseline and each of the following follow-up visits: 6, 12, 24, 36, 48, and 60 month visits | 6, 12, 24, 36, 48 and 60 months |
| Zurich Claudication Questionnaire (ZCQ) | Comparison of ZCQ scores between baseline and each of the following follow-up visits: 6, 12, 24, 36, 48, and 60 month visits | 6, 12, 24, 36, 48 and 60 months |
| SF-36 Health Survey | Comparison of SF-36 scores between baseline and each of the following follow-up visits: 6, 12, 24, 36, 48, and 60 month visits | 6, 12, 24, 36, 48 and 60 months |
| Treatment survival rate | To characterize longevity of the treatment effect of a decompression using the iO-Flex® System. | Ongoing out to 60 months |
| Los Angeles |
| California |
| 90036 |
| United States |
| Orange County Neurological Associates | Mission Viejo | California | 92691 | United States |
| University California Irvine | Orange | California | 92868 | United States |
| Southern California Orthopedic Institute | Van Nuys | California | 91405 | United States |
| Georgetown University | Washington D.C. | District of Columbia | 20057 | United States |
| Medical Center of Trinity | Odessa | Florida | 33556 | United States |
| Florida Orthopaedic Institute | Temple Terrace | Florida | 33637 | United States |
| Resurgens Orthopaedics | Cumming | Georgia | 30041 | United States |
| Suburban Orthopedics | Bartlett | Illinois | 60103 | United States |
| Indiana Spine Group | Carmel | Indiana | 46032 | United States |
| Scott and White Memorial Hospital | Temple | Texas | 76508 | United States |
| VCU Medical Center | Richmond | Virginia | 23219 | United States |
| Tuckahoe Orthopedics | Richmond | Virginia | 23226 | United States |
| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| D013168 | Spondylolisthesis |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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