Penn Tennis
Penn Tennis
Calaxo Bone Screw used for ACL Repair
As medical devices advance in technology the general public is at times used as guinea pigs. Even though we have the FDA on our side, there are many devices on the market that may not have gone through proper testing.
Let’s take a look at a fairly new knee surgery product from Smith & Nephew’s Endoscopy Division, marketed and known as the Calaxo Osteoconductive Interference Screw. This is also commonly called the Calaxo Bone Screw.
This product is used for ACL reconstruction. ACL tears and associated injuries are common in athletes and non-athletes. Anyone who runs, bikes, play tennis or organized sports may encounter ACL injuries. 80% of ACL injuries are from non-contact, meaning that the person may have injured themselves simply by standing, turning or landing wrong. Typical response from the injured is “my knee just gave out”.
When a ACL (anterior cruciate ligament) tear happens the tendon on top of the knee is separated from the knee bone. Surgery is a common fix yet ACL tears do not necessarily require surgery. The medical community is currently debating whether or not to do invasive surgery.
The associated risks of ACL surgery include infection, pain in the knee area, persistent instability, stiffness of the knee joint, and difficulty returning to a previous level of activity. Current estimates show that 90% of patients have no complications with ACL surgery.
The Calaxo Bone Screw is used to help secure grafts in the ACL. The primary feature of this product is that it doesn’t need to be removed. The screw simply dissolves into the surrounding tissue. The average time frame for it to dissolve is approximately 12 months.
This product also contains chemicals that according to the manufacturer “Our CALAXO Osteoconductive Interference Screw is formulated with chemicals that stimulate the bone surface within the tunnel and trigger the development of new bone, which over time replaces the implant. It’s preferable to restore the bone tissue that has been removed to make way for the graft. CALAXO makes this possible.”
Problems associated with the Calaxo Bone Screw are numerous. It is possible that bone may grow over the screw which may interfere in the healing of the ACL. Other problems include swelling of the knee joint, persistent pain in the knee area.
These side effects and problems were noted by Smith & Nephew and they issued a recall of the device. Not only did Smith & Nephew take action, but the legal community also took issue with the device and we’re now seeing a host of law firms investigating the issues and injuries linked to this medical device. There may be a potentially large class action lawsuit in the immediate future.
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