Actively Recruiting
Use of Bone Marrow Concentrate for Treatment of Alar, Accessory, and Transverse Ligament Injuries
Led by Regenexx, LLC · Updated on 2025-04-06
80
Participants Needed
1
Research Sites
662 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Use of Bone Marrow Concentrate for Treatment of Alar, Accessory, and Transverse Ligament Injuries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary signature of the IRB approved Informed Consent
- Skeletally mature male or female aged 18 to 65 years
- Specific injury event causing symptoms occurred less than 10 years ago
- Predominant upper cervical symptoms including headache plus dizziness, vertigo, imbalance, or visual disturbances
- Ability to care for oneself without assistance
- Neck Disability Index (NDI) score of at least 30 (moderate disability)
- Imaging showing specific upper cervical instability criteria on digital motion x-ray or cervical MRI
- Lack of long-term response to conservative care
- Candidate for upper cervical fusion surgery
- Physical exam consistent with upper cervical injury (e.g., tenderness, proprioceptive difficulties)
- Independent, ambulatory, and able to comply with study visits
- Strong desire to avoid surgery
You will not qualify if you...
- Known or diagnosed Ehlers-Danlos Syndrome based on Beighton criteria
- Symptoms related to lower or mid-cervical spine (e.g., facet tenderness, radiculopathy, numbness)
- Prior spinal fusion or surgery in cervical, thoracic, or lumbar spine
- Neck Disability Index (NDI) score greater than 56 (severe disability) unless approved by independent physician
- History of metabolic disorders such as diabetes or eating disorders, or BMI over 40
- Intolerance to injections due to central sensitization or significant pain reactions
- Recent epidural or steroid injections within 6 months
- Prior prolotherapy or platelet-based cervical injections within 3 months
- Radiofrequency ablation to cervical spine within 2 years
- Physical conditions incompatible with procedure or anesthesia
- Inability to tolerate injection position
- Abnormal cervical anatomy increasing procedural risk
- Inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, lupus, psoriatic arthritis)
- Quinolone or statin induced muscle or tendon problems
- Workers' compensation cases or ongoing health-related litigation
- Pregnancy
- Bleeding disorders
- Use of anticoagulant or immunosuppressive medications
- Allergy or intolerance to study medications
- Significant opioid dependence (>20 mg oxycodone equivalent daily)
- Recent drug abuse within 6 months
- Any condition deemed by investigators to preclude enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ehren Dodson
Broomfield, Colorado, United States, 80021
Actively Recruiting
Research Team
E
Ehren R Dodson, PhD
CONTACT
N
Neven Steinmetz, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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