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Pseudarthrosis, a failure of bony fusion, is one of the most common causes of revision surgery following anterior cervical discectomy and fusion (ACDF). The interbody spacer is an important component of bony fusion in ACDF, and we aim to compare machined allograft spacers versus iliac crest allograft in a randomized controlled trial.
Pseudarthrosis, a failure of bony fusion, is one of the most common causes of revision surgery following anterior cervical discectomy and fusion (ACDF). The interbody spacer is an important component of bony fusion in ACDF, and we aim to compare machined allograft spacers versus iliac crest allograft in a randomized controlled trial. We hypothesize that iliac crest allograft will improve anterior cervical discectomy and fusion arthrodesis rates and diminish the amount of intervertebral graft resorption when compared to off-the-shelf machined allografts
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anterior Cervical Discectomy and Fusion (ACDF) w/Machined Allograft | Active Comparator | Participant will undergo primary, elective one-level to four-level ACDF and will be randomized to machined bone allograft |
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| Anterior Cervical Discectomy and Fusion (ACDF) w/Iliac Crest Allograft | Active Comparator | Participant will undergo primary, elective one-level to four-level ACDF and will be randomized to iliac crest bone allograft |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior Cervical Disc Fusion (ACDF) Surgery w/ machined bone allograft | Procedure | Participant will undergo primary, elective one-level to four-level ACDF using machined bone allograft |
| Measure | Description | Time Frame |
|---|---|---|
| Improved participant reported outcome measures (PROMs)-1 | Investigators will ask participants to complete the Short Form-12 survey (SF-12) at 3 months, 6 months, 12 months, and 24 months following surgery | 2 years |
| Improved participant reported outcome measures (PROMs)-2 | Investigators will ask participants to complete the Visual Analog Score (VAS) for Neck and Arm, Neck Disability Index (NDI), at 3 months, 6 months, 12 months, and 24 months following surgery | 2 years |
| Improved participant reported outcome measures (PROMs)-3 | Investigators will ask participants to complete the modified Japanese Orthopaedic Association (mJOA) score) at 3 months, 6 months, 12 months, and 24 months following surgery | 2 years |
| Fusion status after surgery | Fusion status will be assessed using Postoperative x-rays (AP, lateral, flexion, extension) which will be taken at 3 months, 6 months, 12 months, and 24 months following surgery | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothman Orthopaedic Institute | Philadelphia | Pennsylvania | 19107 | United States |
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| Anterior Cervical Disc Fusion (ACDF) Surgery w/ Iliac Crest Bone Graft | Procedure | Participant will undergo primary, elective one-level to four-level ACDF using iliac crest bone allograft |
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