Fusion Status After ACDF

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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

Official Title
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Fusion Status of Machined Allograft Versus Iliac Crest Allograft in Anterior Cervical Discectomy and Fusion: A Randomized Controlled Trial

Conditions
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Spine Fusion, Spine Surgery

Intervention / Treatment
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* Procedure: Anterior Cervical Disc Fusion (ACDF) Surgery w/ machined bone allograft
* Procedure: Anterior Cervical Disc Fusion (ACDF) Surgery w/ Iliac Crest Bone Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients 18 years of age or older preoperative diagnosis of cervical radiculopathy and/or cervical myelopathy. Exclusion Criteria: patients undergoing a revision cervical procedure current smokers patient with surgical indications of tumor, infection, or trauma

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anterior Cervical Discectomy and Fusion (ACDF) w/Machined Allograft<br>Participant will undergo primary, elective one-level to four-level ACDF and will be randomized to machined bone allograft | Procedure: Anterior Cervical Disc Fusion (ACDF) Surgery w/ machined bone allograft<br>* Participant will undergo primary, elective one-level to four-level ACDF using machined bone allograft<br>|
| Active Comparator: Anterior Cervical Discectomy and Fusion (ACDF) w/Iliac Crest Allograft<br>Participant will undergo primary, elective one-level to four-level ACDF and will be randomized to iliac crest bone allograft | Procedure: Anterior Cervical Disc Fusion (ACDF) Surgery w/ Iliac Crest Bone Graft<br>* Participant will undergo primary, elective one-level to four-level ACDF using iliac crest bone allograft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |