In total or partial knee arthroplasty, revision surgery may be required to address problems, including loosening, instability, and infection following an original implant procedure. The summary data in this report includes 576 iTotal implant procedures in 504 patients treated at 46 different centers in the U.K.1 Among all patients treated with Conformis iTotal implants, only three patients (0.5 percent) required revision surgery up to four years following surgery.1
“The new four-year data highlighting the low risk of revision surgery for patients treated with Conformis iTotal implants provides strong clinical evidence reinforcing survivorship of our implant technology,” said Mark Augusti, president and CEO of Conformis. “We are pleased to add this data summary to our growing body of clinical evidence supporting the many benefits our product provides to patients. Announcement of this new safety data is on the heels of our most recent announcement that the Orthopaedic Data Evaluation Panel (ODEP) in the U.K. awarded the Conformis iTotal CR knee replacement system a ‘3A’ rating. This positive 3A rating is based on strong evidence of implant performance over a three-year period; including low revision rates noted in this report.”
“When adopting new technology, surgeons must assess how the new technology maintains established standards for safety and efficacy, “said Raj Sinha, M.D., Ph.D. from S.T.A.R. Orthopedics in Rancho Mirage, CA. “This recent data from the UK demonstrates that the Conformis iTotal CR provides excellent survivorship, evidenced by the low revision rates. This continues to prove the considerable benefits of treating my patients with the Conformis iTotal Knee Replacement System.”
Conformis iTotal is the only patient-conforming total knee replacement for which the implant design and manufacture is based on each patient’s anatomy and offers effective patient based advantages compared to standard off-the-shelf implants, including patient conforming sizes and better bone preservation. Study results from Levengood et. al. published in the peer-reviewed orthopedic journal, The Journal of Knee Surgery, in December 2017 showed that 100 percent of patients treated with iTotal CR achieved mechanical alignment in the target range of +/-3 percent. Neutral mechanical limb alignment (alignment within +/-3°) has previously been linked to better long-term survivorship in TKA, while poor alignment has been linked to higher rates of implant failure.
“As a surgeon, we always strive to provide the best alternatives for our patients,” said Ian McDermott, MB BS, MS, FRCS (Tr&Orth), FFSEM(UK) affiliated with London Bridge Hospital in London, United Kingdom. “This 4-year National Joint Registry data confirms the positive early results I am seeing with my Conformis patients with respect to survivorship, in addition to published studies that continue to show effective positive outcomes I am seeing with faster recovery, improved kinematics and overall patient satisfaction.”
1Implant Summary Report for the iTotal G2 XE and iTotal G2 (Bicondylar tray). Beyond Compliance database February 11, 2018, pages 19-20. This report has been produced by Northgate Public Services (UK) Ltd. (NPS) based on data collected by the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man.