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Fusion Status After ACDF

NCT05986006 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2023-08-14

No results posted yet for this study

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.

Conditions

  • Spine Fusion
  • Spine Surgery

Interventions

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

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-07
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05986006 on ClinicalTrials.gov