Evaluating Bone Marrow Concentrate Injections for Treating Ligament Injuries in the Neck Area with Craniocervical Instability

What this Trial Is About

Researchers are evaluating a new approach to treat injuries of the alar, accessory, and transverse ligaments in patients with craniocervical junction CCJ instability. This study aims to assess the safety and effectiveness of using an anterior approach through the posterior oropharynx combined with bone marrow concentrate therapy. The trial is a single-center, randomized, controlled study that compares two bone marrow concentrate treatments to two sham procedures in patients suffering from symptoms related to CCJ instability, including headaches and dizziness. Participants in the treatment group will undergo bone marrow aspiration from the posterior iliac crest to prepare platelet rich plasma and platelet lysate mixed with bone marrow cells. Under anesthesia, this mixture will be injected into the injured ligaments using fluoroscopy and endoscopic guidance through the posterior oropharynx. Patients will also receive injections to upper cervical ligaments and facets. The control group will receive similar bone marrow aspiration but will undergo sham injections designed to mimic the procedure without the active treatment. Both groups will receive two procedures spaced three months apart. Throughout the study, patients will be assessed using clinical outcome questionnaires and digital motion X-rays at three months following the second procedure. Outcomes include changes in headache impact, neck disability, pain levels, and physical function. Safety will also be monitored through adverse event tracking for six months after treatment. Control participants may opt to receive the active treatment after the initial evaluation period. The total study duration extends up to 2030, with ongoing monitoring and evaluation.

Use of Bone Marrow Concentrate for Treatment of Alar, Accessory, and Transverse Ligament Injuries