Comparing Allograft to Autograft Bone in ACDF Surgeries
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|ClinicalTrials.gov Identifier: NCT03518164|
Recruitment Status : Not yet recruiting
First Posted : May 8, 2018
Last Update Posted : January 31, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Myelopathy||Procedure: Allograft||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Prospective Clinical Trial Comparing the Use of Allograft Bone With Autograft Iliac Crest Bone in Anterior Cervical Spine Fusion Surgeries|
|Estimated Study Start Date :||March 1, 2020|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2025|
Bone from iliac crest
- Smoking survey [ Time Frame: 2 years ]Evaluation of smoking habit
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518164
|Contact: Roxanne Nagurkaemail@example.com|
|Contact: Robert F. Heary, MDfirstname.lastname@example.org|
|Principal Investigator:||Robert F. Heary, MD||Professor|