Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-24 @ 12:20 PM
NCT ID:
NCT03517761
Brief 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.
Detailed 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 lysate (PL) will be derived from the bone marrow aspirate and later mixed with the bone marrow nucleated cell layer for those in the treatment group. 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. Patients will be repositioned in the prone position to then receive upper cervical injections to C0-C3 ligaments and facets. Patients assigned to the sham control condition will also undergo a bone marrow aspiration of 30-60 cc to maintain blinding. Control subjects will receive a sham procedure of a small skin puncture to the posterior oropharynx guided under fluoroscopy while under anesthesia, as well as those pokes to mimic the upper cervical injections to the C0-C3 ligaments and facets. In this group, the BMC will be donated for research purposes and not used clinically. Study patients will be evaluated at 3 months after the 2nd procedure months using patient reported clinical outcome questionnaires and digital motion x-ray. Control patients can crossover to the treatment group after being unblinded at 3-months after the 2nd procedure.
As an alternative to invasive surgery, ligament injections of proliferant agents (prolotherapy) have been proposed to treat cervical instability. Our group has used a blinded flexion-extension radiography to demonstrate that injections of cervical proliferant agents (hypertonic dextrose) into the supraspinous and interspinous ligaments can objectively reduce excessive cervical translation in flexion (Centeno et al. 2005). More recently we have published on the use of bone marrow concentrate to demonstrate MRI evidence of robust ACL ligament signal changes consistent with healing and repair (Centeno et al. 2015).
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.Our 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 carefully selected CCJ instability patients.
Study:
NCT03517761
Study Brief:
Protocol Section:
NCT03517761