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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 : June 5, 2018
Sponsor:
Collaborator:
Cervical Spine Research Society
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 Cervical Radiculopathy Neck Pain Procedure: Anterior cervical discectomy and fusion surgery Not Applicable

  Show Detailed Description

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 : September 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Allograft Bone
Subjects in this arm will receive allograft bone for use in 2 level anterior cervical discectomy and fusion surgery (ACDF surgery).
Procedure: Anterior cervical discectomy and fusion surgery
2 level ACDF surgery

Autograft Iliac Crest Bone
Subjects in this arm will have bone from their iliac crest harvested for use in 2 level anterior cervical discectomy and fusion surgery (ACDF surgery).
Procedure: Anterior cervical discectomy and fusion surgery
2 level ACDF surgery




Primary Outcome Measures :
  1. Fusion [ Time Frame: 1 year post surgery ]
    Determination of whether fusion has occurred based on flexion and extension radiographs


Secondary Outcome Measures :
  1. NDI [ Time Frame: 1 year post surgery ]
    Patient-Reported Outcomes - Neck Disability Index Each of the 10 items on the NDI questionnaire has 5 possible responses and is scored from 0 - 5. The maximum score is therefore 50. To produce a scale range from no disability to complete disability, the raw score is interpreted as follows: 0 - 4 = no disability; 5 - 14 = mild; 15 - 24 = moderate; 25 - 34 = severe; above 34 = complete. If a respondent does not complete a question, the average of all other items is then added to the completed items to produce the total score. The raw score can also be multiplied by 2 to produce a percentage score for reporting purposes.

  2. EQ-5D-5L [ Time Frame: 1 year post-surgery ]
    Patient-Reported Health Outcomes The EQ-5D-5L measures 5 dimensions of quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each question has 5 levels of response ranging from no problems (Level 1) to extreme problems (Level 5). A health state is defined using 1 level from each of the dimensions. A total of 3125 health states are possible. Data is presented as a descriptive health profile, as a measure of overall self-rated health status or as an index value. Using the health profile method, the percentage of subjects reporting each of the levels in each of the 5 dimensions will be reported and compared between the arms of the study. The EQ-5D-5L also contains a VAS to record the respondent's self-rated health. The vertical, visual analogue scale ranges from 0 'Best imaginable health state' to 100 'Worst imaginable health state'. The information is used as a quantitative measure of health outcome as judged by the individual respondents.

  3. PROMIS-PF [ Time Frame: 1 year post surgery ]
    Patient-Reported Outcomes - Physical Function The PROMIS Physical Function short form contains 10 questions. Five of the questions dealing with health limits to physical activities are answered on a scale from "Not at all" (assigned a value of "5") to "cannot do" (assigned a value of "1"). Five questions deal with ability to perform certain activities and are answered on a scale from "Without any difficulty" (assigned a value of "5") to "Cannot do" (assigned a value of "1"). Higher values correspond to a better outcome. Values for the 10 questions are summed to produce a total raw score. Total raw scores are converted into a T-score for each participant using tables/online input applications provided by Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean.

  4. Swallowing [ Time Frame: 6 weeks, 3 months ]
    Clinical outcome as determined by DSQ (Dysphagia Short Questionnaire) The DSQ contains 5 questions related to swallowing. Answers are assigned values ranging from 0 to 4 where 0 indicates no problem and 4 indicates sever difficulty/problem. Values are summed to produce a total dysphagia score where higher values represent a worse outcome.

  5. Pain [ Time Frame: 1 year ]
    Clinical outcome as determined by VAS for neck and arm/shoulder The visual analog scale (VAS) for a patient to report level of pain is a 10 cm horizontal sliding scale ranging from 0 "No pain at all" on the left side to 10 "Worst Imaginable pain" on the right. There is a separate scale for neck pain and fro arm/shoulder pain. The information is used as a quantitative measure of pain in the neck and in the arm/shoulder as reported by the individual respondents.


Other Outcome Measures:
  1. Fusion in sub-group of smokers [ Time Frame: 1 year post-surgery ]
    Examination of whether fusion has occurred based on radiographs in smokers who participate in the study



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:

  • 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 trial.
  • Age between 18 and 80 years.

Exclusion Criteria:

  • 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 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.

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
Contact: Lorelei Pratt, PhD 973-972-4702 lpratt@njms.rutgers.edu
Contact: Robert F. Heary, MD 973-972-2334 heary@rutgers.edu

Sponsors and Collaborators
Rutgers, The State University of New Jersey
Cervical Spine Research Society
Investigators
Principal Investigator: Robert F. Heary, MD Professor

Responsible Party: Robert F. Heary, MD, Professor, Neurosurgery, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03518164     History of Changes
Other Study ID Numbers: 20170000404
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert F. Heary, MD, Rutgers, The State University of New Jersey:
ACDF
allograft
autograft
cervical fusion
NDI
EQ-5D
PROMIS-PF
DSQ

Additional relevant MeSH terms:
Neck Pain
Radiculopathy
Spinal Cord Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Central Nervous System Diseases