A Single-Blinded, Randomized Controlled Trial Evaluating the Use of Bone Marrow Concentrate for the Treatment of Alar, Accessory, and Transverse Ligament Injuries
Regenexx, LLC
Summary
The purpose of this study is to evaluate the effectiveness of using anterior approach through the posterior oropharynx for treating alar and transverse ligament injuries with bone marrow concentrate for patients with craniocervical junction (CCJ) instability.
Description
This study will be a single-center, prospective, single-blinded, randomized, controlled study of patients with CCJ instability that are randomized to either 2 bone marrow concentrate (BMC) treatments or 2 sham procedure to evaluate the safety and effectiveness of using an anterior approach through the posterior oropharynx for treating alar and transverse ligament injuries in addition to upper cervical injection treatment. Patients will undergo a bone marrow aspiration of approximately 30-60 cc from the posterior superior iliac crest for each procedure. Platelet rich plasma (PRP) and platelet l…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: -1) Voluntary signature of the IRB approved Informed Consent, 2) Skeletally mature Male or Female ages 18 to 65 3) Must have a specific inciting injury event that occurred less than 10 years ago where the patient experienced trauma that caused the problem-meaning from that day on, they had the symptoms for which they are now seeking treatment 4) Upper cervical symptoms predominate: Patient must have a headache since the event and must have one of the following: dizziness, vertigo, imbalance, or visual disturbances 5) Patient must be able to care for themselves without assi…
Interventions
- BiologicalBone Marrow Concentrate treatment
While under unconscious TIVA anesthesia, the injectate is then injected under fluoroscopy into the area in need of treatment using an anterior approach through the posterior oropharynx with direct visualization of the injection site via endoscopy. The alar, transverse, and accessory ligaments are the target areas to be treated with the bone marrow concentrate injectate. Patients will be repositioned in the prone position to then receive upper cervical injections to C0-C3 ligaments and facets.Patients will receive 2 of these treatment procedures 3 months apart.
- OtherSham Control
Control subjects will receive a sham procedure of a small skin puncture to the posterior oropharynx guided under fluoroscopy while under anesthesia.Patients will also receive small skin punctures to the back of the neck to mimic ligament and facet injections. Patients will receive 2 of these procedure 3 months apart.
Location
- Ehren DodsonBroomfield, Colorado