Aliso Viejo, CA – January 6, 2014 – OrthAlign, Inc., a privately held medical device company, today announced that more than 13,500 KneeAlign® Total Knee Arthroplasty (TKA) cases have been successfully completed, worldwide. This milestone reflects the continuing and rapid embrace of OrthAlign’s navigation technology for precise alignment, by surgeons throughout the world.
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 and compares favorably to large-console Computer Assisted Surgery (CAS) systems.
In a recent study by Denis Nam, MD (Washington University, St. Louis, MO), 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 by Dr. Nam, 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 this study.
“KneeAlign has helped bring navigation into the reach of many surgeons, providing precision without added complexity. It is an integral part of all my Total Knees,” said Edwin Su, MD (Hospital for Special Surgery, New York, NY). “It’s like my smartphone, hard to imagine life without it.”
Dr. William Bugbee (Scripps Hospital, La Jolla, CA) concurs, stating “KneeAlign is the simplest navigation device I have ever used and it is part of every one of my TKAs.”
- Eliminates intraoperative line of sight issues
- Avoids use of reference arrays and additional pin sites in the tibia and femur
- Does not require any capital investment
- Provides a significantly lower cost per case
- Promotes greater ease of use
“13,500 successful KneeAlign cases is a major achievement for OrthAlign. It further validates our approach in designing and developing smart, innovative products that enable precise knee alignments for thousands of patients in orthopedic surgery, worldwide,” said James Young Kim, OrthAlign’s Vice President of Marketing. “We believe our technology will continue to raise the standard of care in Total Knee and now Total Hip Arthroplasty (THA) surgeries by providing surgeons with user-friendly, cost-effective, surgical navigation solutions for precise alignment.”
The OrthAlign Plus™ system, recently 510k cleared by the United States Food and Drug Administration for THA surgeries, will have fully integrated functionality of KneeAlign, making it the first and only handheld navigation device for use with both Total Hip and Total Knee Arthroplasty surgeries.
About OrthAlign, Inc.
OrthAlign is a privately held medical device company committed to providing orthopedic surgeons with user-friendly, cost-effective, surgical navigation products for precise alignment. We believe that our technology raises the standard of care in Total Knee and Total Hip Arthroplasty surgeries by making consistent and measurable results accessible to all surgeons, hospitals, and patients. Our strategy is to leverage this technology to provide simple and precise alignment solutions for a broad range of orthopedic procedures. For more information regarding OrthAlign, please visit www.orthalign.com.
“ORTHALIGN®, ORTHALIGN PLUS™, KNEEALIGN® are [registered] trademarks of OrthAlign, Inc.”
Published at - News & Events at OrthoAlign, Inc. website