Researchers at Hospital for Special Surgery (HSS) have launched a study to determine if a novel implant allowing for less invasive surgery for a broken wrist leads to a quicker recovery, less post-operative pain and fewer complications compared to conventional surgical treatment.
The HSS study will compile data on an FDA-approved device that requires a much smaller incision and may lead to better results for patients, according to lead investigator Scott Wolfe, M.D., Chief Emeritus of the Hand and Upper Extremity Service at HSS.
The study will follow patients who require surgery for a distal radius fracture, one of the most common types of fractures. The radius is the larger of the two bones in the forearm. The distal section is the part that joins the wrist to the hand.
The radius is the most commonly broken bone in the arm. Distal radius fractures account for approximately one-sixth of fractures treated in United States emergency departments, with more than 640,000 cases reported annually. The most common cause of a distal radius fracture is a fall onto an outstretched arm. Youth who participate in sports and older adults who have osteoporosis are at highest risk.
A cast is frequently used to enable the broken bone to heal. But surgery is needed when someone sustains a complex or displaced wrist fracture, in which the bone breaks in two or more places and the ends are not aligned.
"The most common surgery entails the use of a metal plate and screws to repair the broken bone, which lies in direct contact with the tendons to the fingers, explains Dr. Wolfe. "The new method, known as intramedullary fixation, has recently received more attention because of the minimally invasive procedure required for device implantation, and the fact that no tendons or nerves are touched by the hardware."
The prospective, randomized clinical trial will evaluate the clinical and functional outcomes of the new fixation device, comparing it to traditional surgery using a metal plate and screws.
"Conventional surgery has been linked to tendon rupture, irritation from hardware and hardware removal in a small percentage of cases," Dr. Wolfe said. "A potential advantage of the less invasive procedure is that it avoids trauma to surrounding tendons, nerves, vessels and muscles during surgery. In addition, the new implant is placed within the bone instead of on its surface, so there is very little exposed metal that could irritate the soft tissues."
The novel implant is prepackaged into a small tube. It is then inserted into the wrist through a one inch incision. Once in place, the surgeon carefully expands the implant to support the collapsed bone.
The newer procedure entails an incision that's substantially smaller than the incision made in conventional surgery. "We are studying these implants because it is possible that the less invasive procedure may allow patients to heal faster and return more quickly to normal activities," Dr. Wolfe said.
Patients between the ages of 18 and 80 who require surgery for a distal radius fracture may be eligible for the study.
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