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The purpose of this study is to assess the radiographic and clinical outcomes of spinal fusion following use of Allosync Expand and autograft bone graft.
This is a single site, prospective study with patients selected as study subjects from the Investigator's standard patient population who fulfill the Inclusion/Exclusion Criteria and agree to participate in the study. The study surgery is standard of care, with patients identified as requiring surgery prior to enrollment. The study surgery is lumbar posterior fixation with supplemental posterolateral fusion at from 1 to 3 levels. One side of the posterolateral fusion will be Allosync Expand (utilizing the BMA Angel kit to hydrate) and the other side to autograft bone (control).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allosync Expand | All enrolled patients will received Allosync Expand at 1-3 contiguous levels (L1-S1). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allosync Expand | Device | Allosync Expand is used in lumbar posterolateral arthrodesis at 1-3 contiguous levels (L1-S1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lumbar fusion rate assessed via CT | Lumbar fusion rate assessed via CT at 12 months post surgery | 12 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome via neck visual analog scale (VAS) | Standard of care patient reported neck visual analog scale (VAS) will be used to evaluate patient pain. On a scale of 0 to 10 with a score of 0 being no pain and a score of 10 being worst pain. A low score means a better clinical outcome. A high score means a worse clinical outcome. | 12 months post surgery |
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Inclusion Criteria:
At least 22years of age at the time of consent
Subject must have a documented diagnosis of spondylolisthesis up to Grade I. and have confirmed back and/or radicular pain with associated spinal stenosis as documented by conditions such as:
Subject presents with one or more of the following:
Subject requires lumbar posterolateral arthrodesis at 1-3 contiguous levels (L1-S1).
The number of levels decompressed must equal the number of levels fused.
Subject must have been unresponsive to conservative care for at least 3 months prior to fusion surgery.
Subject must be willing and able to sign an informed consent document.
Subject must be willing and able to return for all follow-up visits, agree to participate in postoperative clinical and radiographic evaluations and comply with the required study regimen.
Exclusion Criteria:
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A patient who meets all inclusion criteria and none exclusion criteria will be enrolled in the study. A patient is considered enrolled upon placement of the Allosync Expand during the surgical procedure. If the surgeon decides intra-operatively not to utilize Allosync Expand, the patient will be considered a screen failure.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Orthopaedic Surgeons | Southfield | Michigan | 48033 | United States |
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| ID | Term |
|---|---|
| D013168 | Spondylolisthesis |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
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| Clinical outcome via Overall Quality of Life (EQ-5D) EuroQol Research Foundation | Standard of care patient reported Overall Quality of Life (EQ-5D) EuroQol Research Foundation will be used to evaluate patient quality of life. On a scale of 3 levels: no problems, some problems, and extreme problems. With a score of "no problems" being no interference in quality of life and a score of "extreme problems" being a high interference in quality of life. "No problems" responses means a better clinical outcome. "Extreme problems" responses mean a worse clinical outcome. | 12 months post surgery |
| Clinical outcome via PROMIS short form - Physical Evaluation | Standard of care patient reported PROMIS short form - Physical Evaluation will be used to evaluate patient physical function. On a scale of 5 levels: without any difficulty, with a little difficulty, with some difficulty, with much difficulty, and unable to do. With a score of "without any difficulty" being no interference in physical function and a score of "unable to do" being high interference in physical function. "Without any difficulty" means a better clinical outcome. "Unable to do" means a worse clinical outcome. | 12 months post surgery |
| D009140 |
| Musculoskeletal Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |