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Comparing Allograft to Autograft Bone in ACDF Surgeries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03518164
Recruitment Status : Not yet recruiting
First Posted : May 8, 2018
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Robert F. Heary, MD, Rutgers, The State University of New Jersey

Brief 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.


Condition or disease Intervention/treatment Phase
Myelopathy Procedure: Allograft Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Arm Intervention/treatment
Allograft
Bone graft
Procedure: Allograft
Bone graft

Autograft
Bone from iliac crest
Procedure: Allograft
Bone graft




Primary Outcome Measures :
  1. Smoking survey [ Time Frame: 2 years ]
    Evaluation of smoking habit



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Only two level anterior cervical discectomy surgeries will be considered. Indications for surgery can be myelopathy, radiculopathy, or mechanical neck pain resulting from instability. Patients for this study are individuals who would be undergoing surgery regardless of the clinical study.
  2. Age between 18 and 80 years.

Exclusion Criteria:

  1. Patients who have previously undergone cervical spine surgery, of any kind, will not be permitted to enroll in this study.
  2. Patients who require only 1 level of surgery or who require surgery for 3 or more levels may not be enrolled.
  3. Surgical issues excluding a patient from enrollment include the need for a corpectomy or the presence of opacification of the posterior longitudinal ligament (OPLL).
  4. Patients requiring regular usage of glucocorticoid medications, for any reasons (rheumatological, pulmonary, immunological, endocrinological, etc.) will be excluded.
  5. Patients taking non-steroidal anti-inflammatory (NSAID) medications would be required to discontinue their medications 10 days prior to the date of surgery and for a minimum of 6 weeks following surgery. If the patient is unable or unwilling to do this, then that patient would be excluded.

Information from the National Library of Medicine

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


Contacts
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Contact: Roxanne Nagurka 973-972-4702 nagurkrm@njms.rutgers.edu
Contact: Robert F. Heary, MD 973-972-2334 heary@rutgers.edu

Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: Robert F. Heary, MD Professor
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Responsible Party: Robert F. Heary, MD, Professor, Neurosurgery, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03518164    
Other Study ID Numbers: 20170000404
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases