NCT05986006

Fusion Status After ACDF

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Spine Fusion
• Spine Surgery

Interventions

Type	Name	Description
PROCEDURE	Anterior Cervical Disc Fusion (ACDF) Surgery w/ machined bone allograft	Participant will undergo primary, elective one-level to four-level ACDF using machined bone allograft
PROCEDURE	Anterior Cervical Disc Fusion (ACDF) Surgery w/ Iliac Crest Bone Graft	Participant will undergo primary, elective one-level to four-level ACDF using iliac crest bone allograft

Timeline

• Start date: 2023-08-07
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2023-08-14
• Last updated: 2023-08-14

Locations

1 site across 1 country: United States