Being able to safely and quickly diagnose Compartment Syndrome
before it causes permanent damage will potentially prevent a patient from having to undergo an intense, very risky and costly surgery called a fasciotomy and a grueling recovery risking the possibility of infection and loss of limb or life the entire time. The complications of doing a fasciotomy are balanced against the even greater risk associated with delayed fasciotomy. Under current protocols, clinicians are concerned there is a bias for over treatment with fasciotomies that are not necessary but the risk of waiting to find out seems greater than the fasciotomy itself.
To medical providers, diagnosis is difficult because of lack of resources
Stryker marketed a device that can measure the pressure inside of a compartment in question however, it is an invasive needle that gets inserted into a compartment that is already hurting tremendously and therefore this method has been largely avoided over the years. Clinicians have relied on clinical suspicion for diagnosing and properly treating these patients. Litigation surrounding this diagnosis is astoundingly popular and a sure confirmation that we have yet to come upon a device or method that we can trust more than clinical suspicion….until now.
A few statistics:
- If a patient has ischemia or lack of blood flow to tissue for 1 hour they will have *reversible neuropraxia (temporary loss of motor and sensory function)
- If a patient has ischemia to tissue for 4 hours, they will have irreversible axonotmesis (nerve damage)
- If a patient has ischemia to tissue for 6 hours, they will have irreversible necrosis, likely limb loss and kidney impairment.
- Of all patients taken to the Operating Room for a fasciotomy within 3 hours of the initial insult or injury, 50% of them had evidence of muscle necrosis *already.
- If a patient has a combined arterial/venous injury, the likelihood of developing compartment syndrome is 41.8%
- A missed diagnosis of Compartment Syndrome increases direct mortality and incredibly increased risk of medical legal involvement.
- The mean cost of defending a case, even if in favor of the provider is $29,500.
- 72% of cases result in verdicts against the provider(s) with an average total payment of $574,680
- MOST PROMINENT FACTOR FOR INDEMNITY PAYMENT WAS A DELAY IN DIAGNOSIS (>8 hours from onset)
- At a presumed extremely low cost to produce this ultrasound device, avoidance of just one malpractice award would pay for hundreds of devices.
- This would help general practitioners, allied health professionals and military personnel to have less need for an orthopedic surgeon acutely. There would be lower cost to monitor a patient because fewer visits, less staff and equipment would be required. This is a HUGE convenience factor for orthopedic surgeons.
- Knowing compartment pressures, continuously and as a trend, could potentially give physicians enough data to decide not to perform a fasciotomy and lower hospital costs. This would lower the associated surgical and hospital recovery costs, which were documented in one study to be two times greater for isolated tibia fracture patients with fasciotomy as compared to those without fasciotomy.
- There is a very high likelihood of insurance reimbursement as well presumably in the 2-3K range per patient. The hospital could recover the cost of the device just by utilizing this device on roughly a dozen patients which would be a source of revenue. It would be just as valuable to properly RULE OUT this diagnosis safely as it is to properly and safely diagnose compartment syndrome so the patient can be treated early and aggressively.
- This would be the ONLY device on the market that is not only NON INVASIVE but also CONTINUOUS which is wildly disruptive to the industry and could easily become the gold standard for diagnosing compartment syndrome.
- Market Potential: The tibia and the radius are the 2 most common long bone fractures to end in compartment syndrome and there are roughly 250,000 of those surgeries annually and that is only 2 of the potential fractures.
- Innovations that address the clinical need for improved compartment syndrome diagnosis and minimize the need for fasciotomy are expected to enjoy significant clinical support in the orthopedic trauma market.