Case Series on Using Bone Marrow Concentrate for Alar Ligament Injuries

Withdrawn

• Conditions: Craniocervical Injuries
• Interventions: Procedure: Alar treatment with BMC using anterior approach

• Registration Number: NCT03557606
• Lead Sponsor: Regenexx, LLC

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2018-05-09
• Study First Submitted QC: 2018-06-04
• Study First Posted: 2018-06-15
• Study Start: 2018-08-20
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-02
• Primary Completion: 2023-05-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 1. Voluntary signature of the IRB approved Informed Consent, 2) Skeletally mature Male or Female ages 18 to 65 3) Disabling symptoms of headache, dizziness, neck pain, or other neuro-musculoskeletal symptoms, that based on physical exam or diagnostic blocks is attributable to the upper cervical spine for >12 months 4) Symptoms exacerbated by activity and relieved by rest 5) Failed all conservative care 6) Hasn't responded long-term to:
  1. C0-C3 facet injections
  2. Upper cervical prolotherapy or PRP into the posterior stabilizing ligaments (nuchal, supraspinous, interspinous ligaments) 7) Considered a likely cervical fusion candidate 8) Imaging (one of the three)
  <!-- -->
  1. Upper cervical MRI showing decreased signal in alar, transverse, PAOM, AAOM, or Tectorial membrane
  2. DMX showing 2 mm or greater lateral overhang of C1 on C2 in lateral bending open mouth view or a V shaped ADI in flexion of increased ADI in flexion
  3. Upper cervical rotatory CT that shows excessive C0-C1 rotation 9) Exam is c/w upper cervical injury (i.e. tenderness along upper cervical facet joints and/or musculature/skull base, good anesthetic block response (>50% pain relief) to C0-C3 intra-articular facet injections, proprioceptive difficulties) 10) Is independent, ambulatory, and can comply with all post-operative evaluations and visits 11) Patient states strong desire to avoid surgery

Exclusion Criteria

• 1. Unable to tolerate injections due to central sensitization (i.e. significant intolerance to manual therapy such as massage, activity such as physical therapy, or an exaggerated pain response to prior injection therapy)

  2. Previous neck surgery that has caused chronic neck pain or radiculopathy 3) Prior epidural or other milligram dose steroid injection in any area or other neck injection therapy within the past 6 months 4) Physical infirmity that is incompatible with the procedure and/or anesthesia required for same 5) Unable to tolerate the injection position 6) Abnormal anatomy seen on MRI imaging that would make the procedure higher risk (e.g. congenital atlanto-axial fusion, atlas assimilation, upper cervical fracture or surgical fusion)

  3. Inflammatory or auto-immune based pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout, pseudo gout) 8) Quinolone or Statin induced myopathy/tendinopathy

  4. Condition represents a worker's compensation case 10) Currently involved in a health-related litigation procedure 11) Is pregnant 12) Bleeding disorders 13) Currently taking anticoagulant or immunosuppressive medication 14) Allergy or intolerance to study medication 15) Use of and significant physical dependence on a chronic opioid (>20 mg oxycodone equivalent per day) 16) Documented history of drug abuse within six months of treatment 17) Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Alar treatment with BMC	Alar treatment with BMC using anterior approach	Patients with CCJ instability that receive Alar treatment with BMC using anterior approach.

Primary Outcome Measures

Name	Time	Method
Headache Impact Test score change from baseline	Change from Baseline to 6 months	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 ).

Secondary Outcome Measures

Name	Time	Method
Headache Impact Test score change from baseline	Change from baseline to 12 months	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 ).
Short Form Health Survey score change from baseline	Change from baseline to 12 months	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.
Numeric Pain scale change from baseline	Change from baseline to 12 months	The within patient mean change from baseline to 12 months in Numeric Pain scale, where 0=no pain and 10=worst possible pain.
Single Assessment Numeric Evaluation improvement rating-modified	Mean at 12 months	Mean improvement scores at 12 months, where -100=100% worse from baseline and 100=100% better or improved from baseline.
C1-C2 overhang	At least 6 months post-procedure	Post-op DMX studies to quantify any reduction in C1-C2 overhang or ADI.
Neck Disability Index score change from baseline	Change from baseline to 12 months	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).
Adverse events	Thru 12 months post-procedure	Any complication or adverse event

Trial Locations

Locations (1)

Centeno-Schultz Clinic; 🇺🇸 Broomfield, Colorado, United States