Fusion Status After ACDF

Not Applicable

• Conditions: Spine Fusion; Spine Surgery
• Interventions: Procedure: Anterior Cervical Disc Fusion (ACDF) Surgery w/ Iliac Crest Bone Graft; Procedure: Anterior Cervical Disc Fusion (ACDF) Surgery w/ machined bone allograft

• Registration Number: NCT05986006
• Lead Sponsor: Rothman Institute Orthopaedics

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.

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

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-03
• Study Start: 2023-08-07
• Study First Submitted QC: 2023-08-09
• Last Update Submitted: 2023-08-09
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anterior Cervical Discectomy and Fusion (ACDF) w/Iliac Crest Allograft	Anterior Cervical Disc Fusion (ACDF) Surgery w/ Iliac Crest Bone Graft	Participant will undergo primary, elective one-level to four-level ACDF and will be randomized to iliac crest bone allograft
Anterior Cervical Discectomy and Fusion (ACDF) w/Machined Allograft	Anterior Cervical Disc Fusion (ACDF) Surgery w/ machined bone allograft	Participant will undergo primary, elective one-level to four-level ACDF and will be randomized to machined bone allograft

Primary Outcome Measures

Name	Time	Method
Improved participant reported outcome measures (PROMs)-3	2 years	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
Fusion status after surgery	2 years	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
Improved participant reported outcome measures (PROMs)-1	2 years	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
Improved participant reported outcome measures (PROMs)-2	2 years	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

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States