Craniocervical Injuries Clinical Trial
Official title:
A Case Series Evaluating the Use of Bone Marrow Concentrate for the Treatment of Alar, Accessory, and Transverse Ligament Injuries
A prospective case series of 200 patients who have been treated with Bone Marrow Concentrate using anterior approach through posterior oropharynx for treating alar, accessory, and transverse injuries for patients with craniocervical junction instability.
The primary objective of this study is to evaluate the clinical outcomes for patient who are
treated with with bone marrow concentrate (BMC) using an anterior approach through the
posterior oropharynx for treating alar and transverse ligament injuries as part of their
clinical care. The case series will observe pre and post-treatment subject-reported clinical
outcomes. Secondary objectives include evaluation of post-treatment complications, adverse
events, re-injections, and surgical intervention, change in use of pain medications, and
changes on post treatment imaging.
The treatment consists of patients undergoing a bone marrow aspiration of approximately 30-60
cc. Platelet rich plasma (PRP) and platelet lysate (PL) will be derived from the bone marrow
aspirate and later mixed with the bone marrow cell layer. While under anesthesia, the
injectate is then injected under fluoroscopy into the area in need of treatment using an
anterior approach through the posterior oropharynx.
One of the challenges of treating the upper cervical ligaments through injection is that they
can't be accessed from the posterior due to obstruction from the cervical spinal cord. The
investigator's group has developed an injection technique using an anterior approach through
the posterior oropharynx, which allows direct access to the ligaments for injection. The goal
of this study is to evaluate the effectiveness of this procedure in CCJ instability patients.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT04770571 -
Posterior Cervical Fixation Study
|
||
| Recruiting |
NCT03517761 -
Use of Bone Marrow Concentrate for Treatment of Alar, Accessory, and Transverse Ligament Injuries
|
N/A |