OrthAlign, Inc., a privately held U.S.-based medical device company, today announced that it has entered into a distribution agreement with Lima France for its Total Knee Arthroplasty (TKA) technology, KneeAlign®.
Approximately 45,000 TKAs are performed in France each year, growing annually at a rate of 10%. Competition amongst implant companies proves to be increasingly fierce, but the French orthopedic market confirms that the future for TKAs lies in technology that improves results, promotes consistency, reduces operating time, decreases patient hospital stays, and reduces patient pain.
KneeAlign provides both tibial and distal femoral navigation in a simple, palm-sized, single-use device and is compatible with all implant systems. It is highly accurate for overall mechanical, tibial, and femoral component alignment in TKA, comparing favorably to large-console Computer Assisted Surgery (CAS) systems.
French orthopedic surgeon, Dr. André Ferreira, of Ancien Interne des Hôpitaux of Lyon, agrees, “KneeAlign is efficient because it provides accurate information about tibial slope and flexion-extension of the femur, which we did not have so accessible before. Varus-Valgus alignment is also beneficial because, previously, we only did valgus estimation of the femur with x-rays. KneeAlign is like CAS, but all of the data and the accuracy are now in the palm of my hand.”
In a recent U.S. study by Denis Nam, MD of Washington University in St. Louis, MO (Nam, et al, “Extramedullary Guides versus Portable, Accelerometer-Based Navigation for Tibial Alignment in Total Knee Arthroplasty: A Randomized Controlled Study”, The Journal of Arthroplasty, June 5, 2013), it was found that KneeAlign decreases the incidence of outliers for tibial component alignment in both the coronal and sagittal planes, and improves the surgeon’s ability to achieve a specific, intraoperative goal, compared to conventional, tibial extramedullary (EM) alignment guides in TKA. In the KneeAlign cohort, 95.7% of tibial components were within 2° of perpendicular to the tibial mechanical axis and 95% of tibial components were within 2° of a 3° posterior slope (compared to 68.1% and 72.1% in the EM cohort, respectively). This study was conducted as a randomized control trial, consisting of five different surgeons.
In another study (Nam, et al, “Accelerometer-Based, Portable Navigation vs Imageless, Large Console Computer-Assisted Navigation in Total Knee Arthroplasty”, The Journal of Arthroplasty, April 17, 2012), significant differences favoring the use of KneeAlign vs. CAS were found with regard to the accuracy of femoral component alignment, with 94.9% of patients in the KneeAlign cohort having an alignment within 2° of neutral vs. 92.5% in the CAS cohort. There was also a significant difference in overall mechanical alignment of the limb, with 92.5% of patients within 3° of a neutral mechanical axis in the KneeAlign cohort vs. 86.3% in the CAS cohort. There was no statistically significant difference in tibial component alignment.
“In order to better provide our customers with effective technology and to best address the needs of French surgeons, we have chosen OrthAlign’s KneeAlign system as our alignment technology of choice,” said Thierry Cassat, General Manager of Lima France. “This system effectively differentiates our product offering in the French marketplace and addresses those immediate needs of our surgeons.”
“As we continue building on our international growth strategy, France is also a very important country for OrthAlign,” said James Young Kim, OrthAlign’s Vice President of Marketing. “We are thrilled to be partnering with Lima France in providing French surgeons with full access to OrthAlign technology. Ultimately, we hope it helps to raise the standard of care in France for TKAs.”
Published at - PR Web