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

Conditions

• Craniocervical Injuries

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Bone Marrow Concentrate treatment — BIOLOGICAL
  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.
• Sham Control — OTHER
  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.

Study Details

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.

Key Dates

Start date

Mar 23, 2018

Status verified

Apr 2025

Primary completion

Dec 31, 2030

Completion

Dec 31, 2030

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Bone Marrow Concentrate treatment
  Bone marrow concentrate subjects 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 nucleated cell layer. Injectate will then be used to treat the ligaments in the CCJ and upper cervical injections to C0-C3 ligaments and facets.
• Sham Comparator: Sham Control
  Control subjects 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 receive sham upper cervical injections to C0-C3 ligaments and facets.

Primary Outcome Measure

Headache Impact Test score change from baseline [ Time Frame: Change from Baseline to 3 months after 2nd treatment ]

Central Contacts

• Ehren R Dodson, PhD
  720-287-7199
  [email protected]
• Neven Steinmetz, PhD
  [email protected]

Locations (1)

Find similar trials in Broomfield, CO

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• Posterior Cervical Fixation Study
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