NCT03557606

Case Series on Using Bone Marrow Concentrate for Alar Ligament Injuries

A Case Series Evaluating the Use of Bone Marrow Concentrate for the Treatment of Alar, Accessory, and Transverse Ligament Injuries

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Regenexx, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Craniocervical Injuries

Interventions

Type	Name	Description
PROCEDURE	Alar treatment with BMC using anterior approach	Patients with CCJ instability will undergo 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 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.

Timeline

• Start date: 2018-08-20
• Primary completion: 2023-05-01
• Completion: 2023-12-31
• First posted: 2018-06-15
• Last updated: 2019-04-02

Locations

1 site across 1 country: United States