Sonoma Orthopedic Products announced that its CRx Clavicle Pin has been featured in a recent study from the Archives of Orthopaedic and Trauma Surgery (March 2015).
The authors (Sinan Zehir, Regayip Zehir, Ercan Sahin, Murat Calbiyik) compared the CRx to minimally-invasive surgical plates for the treatment of displaced clavicle fractures. The authors conducted this study independently and did not receive any funding from Sonoma.
The study compared 24 CRx Pin patients to 21 anatomic plate patients and followed their results for an average of one year.
Unlike anatomic plates that stabilize a fracture by being screwed to the surface of the bone, the CRx Pin is inserted into the bone canal to act as a cast within the bone.
Both treatment options delivered excellent patient results with very few complications. However, operation time was almost 20-minutes faster for the CRx Pin.
Hospital stays were on average one day shorter for CRx patients, and their bones healed two-weeks faster. Additionally, CRx patients were over two-times more satisfied with the physical appearance of the surgical site than the plate patients.
This is a surprising finding because the plate procedure was much less-invasive than that for standard plates. The authors surmised the dissatisfaction was due to patients feeling plates under their skin. All of these findings were statistically significant.
Sonoma is a privately-held medical device company offering proprietary minimally-invasive, fracture repair pins for bones with difficult geometries. The pins may be introduced into the canal of the bone while avoiding joint surfaces and soft-tissue damage.
Once in position, the pins deploy internal fixation talons, instead of screws, which allow healing with lower complication rates than plates.
Compared to plates, clinical data has demonstrated Sonoma pins have faster operative times, require six-times fewer secondary surgeries and experience 34-times fewer removals for patient discomfort.
The technology platforms of Sonoma are broadly protected by thirteen-issued and nine-pending patents along with nine 510(k) clearances covering five indications. Sonoma was founded in 2005, and is headquartered in Buffalo Grove, Illinois.