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).
Study Type
OBSERVATIONAL
Enrollment
40
Allosync Expand is used in lumbar posterolateral arthrodesis at 1-3 contiguous levels (L1-S1)
Michigan Orthopaedic Surgeons
Southfield, Michigan, United States
Lumbar fusion rate assessed via CT
Lumbar fusion rate assessed via CT at 12 months post surgery
Time frame: 12 months post surgery
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.
Time frame: 12 months post surgery
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.
Time frame: 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.
Time frame: 12 months post surgery
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