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FDA releases safety communication on bone graft substitutes

January 29, 2015

The FDA has released a safety communication to inform health care providers that bone graft substitutes containing recombinant proteins or synthetic peptides should not be the first treatment considered for patients younger than 18 years of age with significant bone defects or rare bone disorders.

A press release from the FDA reported results of serious injuries, including excess bone growth, fluid accumulation, inhibited bone healing and swelling, with use of bone graft substitutes containing recombinant proteins or synthetic peptides. Although these events are similar to those seen in patients older than 18, the FDA reported a higher concern in patients younger than 18 due to their overall smaller size and because their bones are still growing.

K2M Group Holdings files registration statement for follow-on offering

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K2M Group Holdings recently announced it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission relating to a proposed follow-on…
In the Journals

Initial PRP injection likely more effective in healing than subsequent injections

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Subsequent injections of platelet-rich plasma have been shown to be less effective than the initial application in cell healing among a healthy volunteer group…
In the Journals

Angles, measurements in robotic-assisted THA match imaging data

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Robotic-assisted total hip arthroplasty was found to be a close match for postoperative imaging results in predicting cup inclination and anteversion angles as well as…
In the Journals

Time to antibiotics, coverage can predict infection of open-tibia fractures

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Infection of type III open-tibia fractures was predicted by time from injury to antibiotics and to wound coverage, according to stud results.Researchers retrospectively…
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Feature Article

Comparison of Nonnavigated and 3-dimensional Image-based Computer Navigated Balloon Kyphoplasty

Orthopedics, January 2015, Volume 38 Issue 1
Balloon kyphoplasty is a common treatment for osteoporotic and pathologic compression fractures. Advantages include…
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CME
Cover

Adjacent Segment Disease: August 2014

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Meeting News Coverage Video
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Larson discusses autograft selection

January 23, 2015
KOLOA, Hawaii – At Orthopedics Today Hawaii 2015, Christopher M. Larson, MD, shares his “pearls” for…
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