ROCKVILLE, Md., Dec. 23 /PRNewswire/ -- FDA today approved a new
injectable cement for use in treating simple wrist fractures that can shorten
the length of time patients must wear a cast.
Normally, to heal a broken wrist, patients wear a cast for six to eight
weeks. Now, when treated with the new product called Norian SRS Cement,
patients may wear a cast for only two weeks followed by a removable splint for
two to four weeks.
Although referred to as cement, the product is different from standard
bone cement used to fix devices in place in joint replacement procedures. The
product is an injectable paste which is used to help hold broken wrist bones
together. The paste begins to harden two minutes after injection and sets
quickly, helping to stabilize the fracture. Over time, it is gradually
replaced by the bone.
This product provides quality of life benefit to patients because the cast
can be removed early. Use of the cement does not eliminate the need for other
stabilizing devices, such as hardware and pins, in patients who would normally
need them.
Although not useful for complex fractures, it will benefit many people
with simple fractures.
Approval was based on a review of safety and effectiveness data submitted
by the manufacturer, Norian Corporation of Cupertino, Calif., and on the
recommendation of the Orthopedics and Rehabilitation Devices Advisory Panel of
FDA's Medical Devices Advisory Committee.
In clinical studies sponsored by the manufacturers, 161 patients with
simple wrist fractures were treated with the product at 23 medical centers in
the United States, Canada and Europe; 162 control patients were treated
conventionally with casts or other fixation devices for six to eight weeks.
Patients were followed for one year.
The study showed that the new product was as effective as the conventional
treatments in healing the fracture, and the rate of complications was about
the same at the end of one year.
However, certain patients who received this product lost more bone length
than their counterparts treated conventionally.
FDA is requiring the company to conduct a post-approval study of the
product's longer-range safety -- especially the long term risk of re-fracture.
In addition, FDA is requiring the firm to conduct a long-term animal study to
evaluate the potential for the product to cause degeneration of the joint
(arthritis).
Consumer Inquiries: 800-INFO-FDA
SOURCE Food and Drug Administration
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Related links:
http://www.fda.gov
CONTACT:
Food and Drug Administration, Sharon Snider,
301-827-6242; Broadcast Media: 301-827-3434
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