In short
In a form of preventive medicine, French company HyPrevention is on a mission to prevent osteoporosis-related hip fracture on the contralateral side following an initial fracture. Its product, H.I.P. CONCEPT is an implantable device, manufactured from PEEK and now undergoing study to establish whether it has a place in preventing contralateral fracture in patients at risk due to bone fragility linked to osteoporosis.
Background
It’s an interesting concept, this implantation of a device to prevent a traumatic injury. We can’t really think of another example. But when you think about it, with hip fracture affecting more than 2 million people worldwide every year and 9% of patients suffering a contralateral fracture at a year (20% at five years), why not? According to a HyPrevention press release, after a second contralateral fracture, loss of autonomy is almost certain to prevent a return home and mortality is multiplied by 2.
And it’s not as though you have to undertake a second does of anaesthetic, because the implantation of a contralateral H.I.P. CONCEPT is performed at the same time as the treatment of the original fracture. The duration of hospitalization remains unchanged and the procedure demands no specific rehabilitation.
A clinical trial has been approved by the French MSNA (National Security Agency of Medicines and Health Products), and two patients presenting with a hip fracture have already had the procedure performed on them. The patient selection criteria clearly need to be carefully controlled. In the case of the first patients, they were in good general condition but were judged to have a subsequent risk of falling, which increased the fear for a second, contralateral fracture.
The duration of surgery was 35 minutes in both cases and both patients left the hospital after 5 days. They are doing well. They will be followed over a period of 5 years. New cases are expected in the context of this trial.
Whether you’re a healthcare provider or an orthopaedic surgeon, we’re not quite sure how you should interpret all of this. There is indeed an argument for prevention of contralateral hip fracture if it improves the quality of life of older people by allowing them to retain their independence. Indeed for “young” active seniors, who have brittle bone quality resulting in a first fracture, prevention is highly likely to lead to an increased life expectancy, all of which suggests there may be sound healthcare economic arguments behind the procedure. Whether the specialty buys the clinical evidence that is sure to appear, will be interesting to see.
The use of H.I.P. CONCEPT is also being studied in oncology to consolidate and strengthen biomechanically tumor-induced lesions before fracture occurs.
Source: HyPrevention SAS, Business Wire
published: March 25, 2013 in: Clinical Studies/Trials, Hip, Techniques, Trauma