Fusion Status After ACDF
Fusion Status of Machined Allograft Versus Iliac Crest Allograft in Anterior Cervical Discectomy and Fusion: A Randomized Controlled Trial
1 other identifier
interventional
124
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2023
CompletedStudy Start
First participant enrolled
August 7, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedAugust 14, 2023
August 1, 2023
1.1 years
August 3, 2023
August 9, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Anterior Cervical Discectomy and Fusion (ACDF) w/Machined Allograft
ACTIVE COMPARATORParticipant will undergo primary, elective one-level to four-level ACDF and will be randomized to machined bone allograft
Anterior Cervical Discectomy and Fusion (ACDF) w/Iliac Crest Allograft
ACTIVE COMPARATORParticipant will undergo primary, elective one-level to four-level ACDF and will be randomized to iliac crest bone allograft
Interventions
Participant will undergo primary, elective one-level to four-level ACDF using machined bone allograft
Participant will undergo primary, elective one-level to four-level ACDF using iliac crest bone allograft
Eligibility Criteria
You may qualify if:
- patients 18 years of age or older
- preoperative diagnosis of cervical radiculopathy and/or cervical myelopathy.
You may not qualify if:
- patients undergoing a revision cervical procedure
- current smokers
- patient with surgical indications of tumor, infection, or trauma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2023
First Posted
August 14, 2023
Study Start
August 7, 2023
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
August 14, 2023
Record last verified: 2023-08