Fusion Status After ACDF

Rothman Institute Orthopaedics124 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

124

Conditions

Spine Fusion Spine Surgery

Interventions

Anterior Cervical Disc Fusion (ACDF) Surgery w/ machined bone allograftPROCEDURE

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 GraftPROCEDURE

Participant will undergo primary, elective one-level to four-level ACDF using iliac crest bone allograft

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 2 years

Data from ClinicalTrials.gov

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