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Procedure
Bone Graft Types for ACDF in Spinal Fusion
N/A
Waitlist Available
Research Sponsored by Rothman Institute Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will compare two types of bone grafts to see which works best in a common neck surgery.
Who is the study for?
This trial is for adults over 18 with cervical radiculopathy or myelopathy needing anterior cervical discectomy and fusion (ACDF) surgery. It's not open to those who need revision surgery, have tumors, infections, trauma-related conditions, or are current smokers.Check my eligibility
What is being tested?
The study compares two types of bone grafts used in ACDF surgeries: one group receives a machined bone allograft while the other gets an iliac crest bone graft. The goal is to see which type better prevents pseudarthrosis—a failure of bony fusion.See study design
What are the potential side effects?
Potential side effects from the procedures may include pain at the graft site, infection risk, nerve damage risks associated with spine surgery, and possible complications related to non-fusion of the bones.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fusion status after surgery
Improved participant reported outcome measures (PROMs)-1
Improved participant reported outcome measures (PROMs)-2
+1 moreTrial Design
2Treatment groups
Active Control
Group I: Anterior Cervical Discectomy and Fusion (ACDF) w/Machined AllograftActive Control1 Intervention
Participant will undergo primary, elective one-level to four-level ACDF and will be randomized to machined bone allograft
Group II: Anterior Cervical Discectomy and Fusion (ACDF) w/Iliac Crest AllograftActive Control1 Intervention
Participant will undergo primary, elective one-level to four-level ACDF and will be randomized to iliac crest bone allograft
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Who is running the clinical trial?
Rothman Institute OrthopaedicsLead Sponsor
121 Previous Clinical Trials
21,454 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having a follow-up surgery on my neck.I am 18 years old or older.I need surgery for a tumor, infection, or injury.I have been diagnosed with nerve or spinal cord issues in my neck.
Research Study Groups:
This trial has the following groups:- Group 1: Anterior Cervical Discectomy and Fusion (ACDF) w/Machined Allograft
- Group 2: Anterior Cervical Discectomy and Fusion (ACDF) w/Iliac Crest Allograft
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for patients to participate in this research at the present time?
"This clinical trial is not accepting new participants according to the information on clinicaltrials.gov; it was initially published August 7th, 2023 and its last update occurred two days later. Despite this, 41 other trials are presently enrolling patients at this time."
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