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Comparing Allograft to Autograft Bone in ACDF Surgeries

NCT03518164 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-09-24

No results posted yet for this study

Summary

Anterior cervical discectomy and fusion (ACDF) is a surgery performed from the front of the neck in which damaged discs are removed and a bone graft is inserted into the space to allow the bone to grow together to set up a bridge or fusion between the bones of the spine. The purpose of this study is to determine whether there is an advantage to using autograft (bone material taken from the patient's own hip) or allograft (bone material derived from other sources) when performing ACDF. Both of these materials are routinely used by surgeons in ACDF surgeries. Neither is experimental.

Subjects who participate in this study will be randomized to receive either allograft or autograft bone for the surgery. They will receive the 2 level ACDF surgeries routinely employed by the surgeons. The same screw-plate fixation will be used for all subjects in the trial and the same allograft material will be used for all subjects who are randomized to the allograft arm of this study.

A determination will be made as to whether there is a difference in fusion rates associated with the choice of either allograft bone or autograft bone based on the subjects' x-rays one year post surgery. The study will also determine whether there are differences in clinical and functional outcomes associated with the choice of bone graft as measured by patient-reported outcomes instruments collected. In addition, the study will examine whether there are differences in clinical and radiographic outcomes based on choice of bone graft for the subgroup of smokers participating in the study. Overall hospitalization costs will also be obtained and compared as an indication as to whether one method or the other may be superior from a financial standpoint.

Conditions

  • Myelopathy

Interventions

PROCEDURE

Allograft

Bone graft

Sponsors & Collaborators

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Robert F. Heary, MD · Professor

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2020-08-25
Completion
2020-08-25

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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 NCT03518164 on ClinicalTrials.gov