Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03518164 |
| Other study ID # |
20170000404 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2020 |
| Est. completion date |
August 25, 2020 |
Study information
| Verified date |
September 2021 |
| Source |
Rutgers, The State University of New Jersey |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
The study is a prospective, randomized multicenter trial. Approximately 200 subjects will be
enrolled at 12 sites throughout the United States and Canada. Up to 250 subjects may be
enrolled to account for screen failures. Rutgers, New Jersey Medical School is the
coordinating center for the study. 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.
Using a computer randomization program, the central study coordinating site will randomize
subjects in a 1:1 ratio to either the autograft or allograft arm of the trial. Surgery is
then scheduled in the routine manner. The same ACDF surgeries routinely employed by study
surgeons will be performed with screw-plate fixation using the same Medtronic system for all
surgeries. In addition, all surgeons will use the same allograft struts, also be provided by
Medtronic [Cornerstone].
Postoperative management will be the usual and customary procedures followed by the spine
surgeons participating in the trial. This would include a wound check at some point in the
first two weeks following discharge with clinical and radiographic studies performed at 6
weeks, 3 months, 6 months, 1 year, and 2 years after the index surgery. Baseline and 1 year
postoperative X-rays will be collected for the study. As the "gold standard" for the
evaluation of fusion is the presence of bridging trabecular bone across an intended fusion
interspace as well as the lack of motion between the spinous processes at the treated levels,
dynamic plain film radiographs in neutral, flexion and extension will be obtained to
determine fusion status. Neuroradiologists will review the subjects' 1 year radiographs. If
these images are unable to definitively clarify whether a fusion has occurred at the 1 year
time point, then CT scan examinations would be obtained as standard of care to make the
determination. Review of these CT scans for the trial would also be performed by a blinded
study radiologist. Sagittal and coronal reconstructed views will be generated. All subjects'
imaging studies will be reviewed by a Board certified radiologist certified in
neuroradiology. The flexion and extension cervical spine radiographs would be obtained to
determine motion between the spinous processes and the presence of bridging trabecular bone.
This will include preoperative and postoperative (1 year) imaging in which the
neuroradiologist will be blinded to the readings of any outside radiologists or surgeons. At
1 year, the neuroradiologist will provide a binomial response of either "fused" or "not
fused". Partial fusions will be considered not fused for the purposes of this study. The
decision of the blinded neuroradiologist will be final regardless of the surgeon's
impressions of the imaging studies.
Subject visits will occur at the patients' standard of care clinical visits at
baseline/screening and at 6 weeks, 3 months, 6 months, 1 year and 2 years post-surgery. Study
questionnaires and routine physician evaluations will be completed at each of these visits.
X-rays will be collected and reviewed at the baseline and 1 year visits. A CT scan will be
collected at 1 year only in the event that radiographs cannot determine whether fusion has
occurred. Subjects will be monitored for adverse events at each visit.
Complications related to the cervical and the iliac regions will be carefully observed. In
the cervical spine, the complications would include: persistent neck pain, persistent arm
pain, new neurological findings, instrumentation failure, fusion failure, dysphagia, and
voice issues (hoarseness and/or weakness). Specific to the iliac patients, complications
related to pain, bleeding, infection, development of meralgia paresthetica, pelvis fracture,
or other findings related to the iliac harvest would be catalogued. If reoperation is
necessary, this will be recorded on a Report of Second Cervical Surgery as well the reason
for the reoperation. Complications such as graft dislodgement, extrusion, or collapse will be
noted. Instrumentation failure resulting in screw and/or plate fracture will be recorded.
Reoperations for any reason will be identified and specific observation will be made as to
whether a pseudoarthrosis was present as the rationale for the reoperation. In addition,
clarification as to whether surgery was needed for an adjacent segment issue next to a
previously successful fusion will be documented.
Due to concerns with swallowing dysfunction following anterior cervical surgery, all patients
in the study will be evaluated prior to the surgery and at routine follow-up time points with
the Dysphagia Short Questionnaire (DSQ).
Smokers will be included in the study and their patient-reported status with respect to the
level of use of nicotine containing products will be documented at each visit. All smokers
will be encouraged to quit smoking prior to the surgeries.
Both disease- specific and general patient outcomes will be analyzed at regular intervals.
Outcomes related to neck pain, arm pain, and neurological abnormalities will be assessed. The
following patient-reported outcomes measures will be administered to subjects prior to
surgery and at 6 weeks, 3 months and 6 months, 1 year and 2 years: DSQ, PROMIS-PF, EQ-5D-5L,
NDI, and VAS (arm and neck and iliac crest-if applicable).
