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.
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.
Study Type
OBSERVATIONAL
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.
Centeno-Schultz Clinic
Broomfield, Colorado, United States
Headache Impact Test score change from baseline
The within patient mean change from baseline to 6 months in Headache Impact Test scores. Scale of 36-78; HIT-6 scores 36-49 (little to no impact), HIT-6 scores 50-55 (moderate impact), HIT-6 scores 56-59 (substantial impact), HIT-6 scores 60-78 (severe impact ).
Time frame: Change from Baseline to 6 months
Headache Impact Test score change from baseline
The within patient mean change from baseline to 6 months in Headache Impact Test scores. Scale of 36-78; HIT-6 scores 36-49 (little to no impact), HIT-6 scores 50-55 (moderate impact), HIT-6 scores 56-59 (substantial impact), HIT-6 scores 60-78 (severe impact ).
Time frame: Change from baseline to 12 months
Neck Disability Index score change from baseline
The within patient mean change from baseline to 6 months in Neck Disability Index scores. Scale of 0-50; 0-4 points (no disability), 5-14 points (mild disability), 15-24 points (moderate disability), 25-34 points (severe disability), 35-50 points (complete disability).
Time frame: Change from baseline to 6 months
Neck Disability Index score change from baseline
The within patient mean change from baseline to 12 months in Neck Disability Index scores.scores. Scale of 0-50; 0-4 points (no disability), 5-14 points (mild disability), 15-24 points (moderate disability), 25-34 points (severe disability), 35-50 points (complete disability).
Time frame: Change from baseline to 12 months
Short Form Health Survey score change from baseline
The within patient mean change from baseline to 6 months in Short Form Health Survey. Two summary scores are derived; the Physical component scale and the Mental component scale, each on a scale of 0-100, where the higher the score, the better the health.
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Time frame: Change from baseline to 6 months
Short Form Health Survey score change from baseline
The within patient mean change from baseline to 12 months in Short Form Health Survey. The within patient mean change from baseline to 6 months in Short Form Health Survey. Two summary scores are derived; the Physical component scale and the Mental component scale, each on a scale of 0-100, where the higher the score, the better the health.
Time frame: Change from baseline to 12 months
Numeric Pain scale change from baseline
The within patient mean change from baseline to 6 months in Numeric Pain scale, where 0=no pain and 10=worst possible pain.
Time frame: Change from baseline to 6 months
Numeric Pain scale change from baseline
The within patient mean change from baseline to 12 months in Numeric Pain scale, where 0=no pain and 10=worst possible pain.
Time frame: Change from baseline to 12 months
Single Assessment Numeric Evaluation improvement rating-modified
Mean improvement scores at 6 months, where -100=100% worse from baseline and 100=100% better or improved from baseline.
Time frame: Mean at 6 months
Single Assessment Numeric Evaluation improvement rating-modified
Mean improvement scores at 12 months, where -100=100% worse from baseline and 100=100% better or improved from baseline.
Time frame: Mean at 12 months
Adverse events
Any complication or adverse event
Time frame: Thru 12 months post-procedure
C1-C2 overhang
Post-op DMX studies to quantify any reduction in C1-C2 overhang or ADI.
Time frame: At least 6 months post-procedure