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RECRUITING
NCT03517761
NA

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

Sponsor: Regenexx, LLC

View on ClinicalTrials.gov

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.

Official title: A Single-Blinded, Randomized Controlled Trial Evaluating the Use of Bone Marrow Concentrate for the Treatment of Alar, Accessory, and Transverse Ligament Injuries

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2018-03-23

Completion Date

2030-12

Last Updated

2025-04-06

Healthy Volunteers

No

Interventions

BIOLOGICAL

Bone 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.

OTHER

Sham 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.

Locations (1)

Ehren Dodson

Broomfield, Colorado, United States