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Analyzing CCI Procedure Failures: The SpaceX Approach

Published on Jul 3, 2022

[The above video is a summary of this blog.]

In any real medical procedure, there are always analyses of why patients fail to respond. This week I went through that process for a unique procedure I developed to help patients suffering from Craniocervical Instability (CCI). Let’s dig into that analysis and learn what it tells us about the nature of instability, symptoms, and interventional orthobiologics.

Magic vs Medicine

Regenerative medicine right now has two big categories. One is magic. What I mean by that is that most of what the public gets offered these days has no clinical research or analysis behind it, just the idea that magic stem cells or exosomes or some other substance will make their body heal. The magical thinking often extends to providing cells intravenously which magically end up in places with a poor blood supply. This camp is treating all sorts of incurable diseases from ALS to MS to aging.

The real medicine camp is very different. Here the focus is on using data analysis to make regenerative medicine better. This camp is where most serious practitioners of interventional orthobiologics live. For example, rather than the magic statement that injecting stem cells will make you younger, which would take decades to prove, this camp is focused on the two dozen Randomized Controlled Trials (RCTs) that show that Platelet-Rich Plasma helps knee arthritis. Or using registry data as we do at Regenexx, to see which patients are failing procedures like bone marrow concentrate and using that data to pick better candidates. Today we’re focusing on the real medicine camp.

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Understanding Treatment Failure is the First Step in Dialing in Outcomes

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Any process produces results. Analyzing why the process didn’t produce the desired result is a key part of quality improvement. Take SpaceX which has dialed in reusable rockets faster than any other group in world history. How did they do that?

If you compare the SLS program at NASA to SpaceX’s Falcon program there are huge disparities. SLS is the system that was designed through the traditional cost-plus government contracting process at NASA to take astronauts back to the moon. It’s not reusable and way behind schedule and over budget. The SpaceX Falcon program soared past the better-funded SLS years ago and now is placing dozens of launches a year in orbit with reusable rockets while SLS has yet to fly a single rocket.

If you look at a breakdown of the culture at SpaceX, it’s completely different than NASA and its defense contractors. SpaceX prototypes and puts a quality rocket in the air. If there are issues, they quickly learn from those problems and quickly re-prototype and re-fly. NASA is the opposite. They spend billions and many years trying to make sure that the one rocket they put up as a prototype is perfect. The proof is in the pudding now, the SpaceX approach has produced better rockets, more quickly, and for MUCH less money. Meaning that SpaceX’s “learning from failure” process has shown NASA what it’s been doing wrong.

In medicine, physicians often do the same thing. There are many research papers focused on why certain patients fail a procedure. The hope is that through that analysis, doctors can learn which patients to avoid or whether there are ways to improve the procedure. This morning we’ll do that with the PICL procedure.

CCI and the PICL Procedure

CCI stands for Craniocervical Instability. These patients have lax ligaments that hold the head to the upper neck. As you might imagine, this causes all sorts of havoc like headaches, neck pain, and dizziness due to beat-up upper neck joints, irritated nerves, and compressed blood vessels. The usual treatment for this problem is an upper cervical fusion, which makes the area not move at all. These are very big and complication-laden procedures, so anything that can help these patients avoid that surgery is good news.

About half a decade ago I developed a procedure that targeted these lax ligaments. That wasn’t easy, as, like many things developed by our team, there was no textbook on how this should be done. However, eventually, that effort led to the PICL procedure, where the alar, transverse, accessory, and other critical ligaments could be injected with bone marrow concentrate using a novel approach. The goal was to tighten these damaged and loose ligaments to get rid of the instability without fusion.

Given that research has supported that you could diagnose these loose head/neck ligaments using a technology called Digital Motion X-ray, it seemed logical to track a number of patients before and after this procedure to see if the abnormal motion improved (1). We did this early on and observed significant objective decreases in instability about 70% of the time. Hence, we stopped getting routine before and after images as we had achieved objective proof of concept.

Analyzing PICL Treatment Failures

For the PICL procedure, we generally see about 70% of patients who improve with the procedure. How much often depends on where patients begin their journey. For example, we have some patients who are minimally impacted by their CCI and some who are completely disabled. Hence if you begin as a person who is disabled and unable to stay upright for more than an hour a two a day, your outcome will be different than someone who was just unable to exercise because of headaches and dizziness.

What’s happening to the 30% who don’t respond? Are they just not appropriate for the procedure or do they need more procedures? That’s the question I recently set out to ask.

In any instability scenario where injections are used to heal and tighten damaged ligaments, the question is how many injection sessions does it take to make something stable. We’ve published research in this area in the neck and peripheral joints (2-6). For example, we have seen objective evidence of improvement in stability on flexion-extension x-rays for the neck and MRI imaging for injured knee anterior cruciate ligaments when these problems were treated with precise orthobiologic injections. For neck patients using prolotherapy, our experience is that it can take 2-4 treatments to get to full stability.

Hence, it’s reasonable to ask that if you have a patient who didn’t respond to their first PICL procedure with noticeable improvement in symptoms, do they just need more treatment or is the treatment not appropriate for their condition? To make that decision, repeating the DMX looking for objective improvements in instability would seem to be the first step.

Repeating DMX in First PICL No Response Cases

For this small case series, I reviewed patients who:

Had no or little symptomatic relief with their first PICL procedure
Were my patient
Had a DMX performed by the local Dr. Katz office where we know the images are higher quality
Had Abnormal C1-C2 Overhang before the procedure as defined by the Freeman/Katz/Rosa et al paper
Had a comparison second DMX after the first PICL performed in the last 12 months

That review yielded 6 cases. These second DMX studies were then remeasured by a third party and compared to the first pre-PICL DMX. The results?

4/6 of the first PICL procedure symptom failures demonstrated significant objective improvements in instability (these DMX comparisons are reviewed in the video above). What does that tell me? That there’s a significant chance that I had not reduced instability enough to allow for symptom improvement and that a second PICL procedure is reasonable.

What are other possibilities for these patients? One is certainly that their instability has been going on long enough to cause serious damage to joints and/or nerves such that improving instability still leaves these structures causing pain or other symptoms like dizziness. If that’s what’s happening, then if the second PICL procedure normalizes the DMX, we will need to go onto diagnostic blocks to better determine which structures are causing the symptoms and what can be done using orthobiologics to help.

Comparing This Process to Fusion

One of the hardest concepts for patients to grasp is the ladder of invasiveness. For example, a less invasive procedure that may help should always be tried before a more invasive procedure is considered. I see patients all day long who jump into big surgical procedures without considering this ladder and some who are left with serious lifelong complications because they didn’t understand or respect this rule. Obviously, the PICL procedure as a precision injection of bone marrow concentrate is less invasive than fusion, so the order of therapies here should be PICL first (if the patient is a reasonable candidate) and upper neck fusion only if PICL fails.

The goal of a fusion is to make an unstable spinal level not move at all. The problem is that once you do that, you can never go back. For example, you can’t undo a spinal fusion if that procedure doesn’t help your symptoms. In addition, there is a serious risk of complications in these upper neck fusion procedures. Hence, if a repeat DMX after one or more PICL procedures shows that the instability has resolved and the symptoms remain, then that patient is less likely to benefit from a fusion. If there is no improvement in instability, then a fusion may well be warranted. While that’s a simplification of all the variables involved in making a decision on which CCI patients to operate, it’s certainly something that should be considered.

The upshot? Looking at what’s going on in patients that fail a treatment is often as or more important than focusing on those who responded. In this case, the good news is that the objective data still points in the direction that PICL helps stability. While in most patients that corresponds to an improvement in symptoms and improved function, the unanswered question is whether in some patients, is that enough?

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References:

(1) Freeman MD, Katz EA, Rosa SL, Gatterman BG, Strömmer EMF, Leith WM. Diagnostic Accuracy of Videofluoroscopy for Symptomatic Cervical Spine Injury Following Whiplash Trauma. Int J Environ Res Public Health. 2020 Mar 5;17(5):1693. doi: 10.3390/ijerph17051693. PMID: 32150926; PMCID: PMC7084423.

(2) Centeno CJ, Elliott J, Elkins WL, Freeman M. Fluoroscopically guided cervical prolotherapy for instability with blinded pre and post radiographic reading. Pain Physician. 2005 Jan;8(1):67-72. PMID: 16850045.

(3) Centeno CJ, Elkins W, Freeman M, Elliott J, Sterling M, Katz E. Total cervical translation as a function of impact vector as measured by flexion-extension radiography. Pain Physician. 2007 Sep;10(5):667-71. PMID: 17876363.

(4) Centeno C, Markle J, Dodson E, Stemper I, Williams C, Hyzy M, Ichim T, Freeman M. Symptomatic anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow concentrate and platelet products: a non-controlled registry study. J Transl Med. 2018 Sep 3;16(1):246. doi: 10.1186/s12967-018-1623-3. PMID: 30176875; PMCID: PMC6122476.

(5) Centeno CJ, Pitts J, Al-Sayegh H, Freeman MD. Anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow nucleated cells: a case series. J Pain Res. 2015 Jul 31;8:437-47. doi: 10.2147/JPR.S86244. PMID: 26261424; PMCID: PMC4527573.

(6) Centeno C, Lucas M, Stemoer I, Dodson E. IMAGE-GUIDED INJECTION OF ANTERIOR CRUCIATE LIGAMENT TEARS WITH AUTOLOGOUS BONE MARROW CONCENTRATE AND PLATELETS: MIDTERM ANALYSIS FROM A RANDOMIZED CONTROLLED TRIAL. Bio Ortho J Vol 3(1):e29–e39; October 5, 2021.