Fusion Status After ACDF

Spine Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05986006
• Other study ID #: AHIL22D.618
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 7, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: August 2023
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 124
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spine Fusion
• Spine Surgery

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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