Comparing Allograft to Autograft Bone in ACDF Surgeries

NCT03518164 | Withdrawn DMC

• 1 other identifier: 20170000404
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myelopathy

Outcome Measures

Primary Outcomes (1)

• Smoking survey

  smoking

  2 years

Study Arms (2)

Allograft

OTHER

Bone graft

Procedure: Allograft

Autograft

OTHER

Bone from iliac crest

Procedure: Allograft

Interventions

Allograft PROCEDURE

Bone graft

Allograft; Autograft

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age between 18 and 80 years.

You may not qualify if:

• Patients who have previously undergone cervical spine surgery, of any kind, will not be permitted to enroll in this study.
• Patients who require only 1 level of surgery or who require surgery for 3 or more levels may not be enrolled.
• Surgical issues excluding a patient from enrollment include the need for a corpectomy or the presence of opacification of the posterior longitudinal ligament (OPLL).
• Patients requiring regular usage of glucocorticoid medications, for any reasons (rheumatological, pulmonary, immunological, endocrinological, etc.) will be excluded.
• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

MeSH Terms

Conditions

Spinal Cord Diseases

Interventions

Transplantation, Homologous

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Robert F. Heary, MD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Neurosurgery

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 8, 2018
• Study Start: March 1, 2020
• Primary Completion: August 25, 2020
• Study Completion: August 25, 2020
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share