Bedford, Mass. – August 3, 2015 – ConforMIS, Inc. (NASDAQ: CFMS) announced today results from six clinical studies presented at the 2015 Pan Pacific International Congress for Joint Reconstruction (ICJR). In an ongoing, blinded, US multicenter study, the investigators reported that patients with customized ConforMIS iTotal CR knee replacements were more likely to have an excellent or good objective Knee Society Score (KSS) and walked statistically significantly faster than patients with standard, off-the-shelf total knee replacements.
For this study, researchers at seven US centers performed an interim analysis of 295 consecutively enrolled total knee replacement patients using a variety of functional tests and the KSS, a validated testing instrument used to assess patient outcomes. The objective component of the KSS measures factors such as range of motion, alignment, and stability, which are important for regaining functional abilities. Patients with iTotal CR knee replacements were 1.7 times more likely to achieve an excellent or good objective KSS, whereas patients with off-the-shelf knee replacements were 2.6 times more likely to achieve a poor objective KSS.
In a separate, validated functional test administered during this study, known as the Aggregated Locomotor Function (ALF) test, blinded operators assessed patients’ ability to perform various activities of daily living, including walking, standing from a chair and climbing stairs. Patients with iTotal CR knee replacements showed a statistically significantly better ALF score than patients with off-the-shelf knee replacements. In addition to achieving an overall better ALF score, the data also showed statistical significance in one individual component of the ALF test: patients with iTotal CR knee replacements walked statistically significantly faster than patients with off-the-shelf knee replacements.
“After performing several thousand total knee replacements, I have seen firsthand that using a customized implant designed specifically for each patient could have a significant impact on restoring function and improving overall patient satisfaction and ability to perform daily activities,” said Robert Tait, MD, Chief of Staff at St. Rose Dominican Hospital Siena in Henderson, Nev., and lead investigator on this clinical study. “This new data provides additional clinical evidence demonstrating that customized knee implants can deliver measurable advantages for patients that have a direct and positive impact on patient quality of life.”
Other studies presented at ICJR evaluated the ConforMIS iTotal CR knee replacement with regard to kinematics, safety profile and patient satisfaction:
- The lead investigator in a prospective, single-arm, multicenter study of 252 patients with iTotal CR knee replacements presented results at ICJR that showed high patient reported outcome scores, high range of motion, short hospital stay and excellent safety profile.
- In two other studies, investigators used real-time x-ray imaging with mobile fluoroscopy to study the movement, or kinematics, of the knee during deep knee bend and chair rise in patients with iTotal CR knee replacements compared to patients with off-the-shelf knee replacements. In the first study, investigators analyzed a total of 63 total knee replacements implanted by a single surgeon. The investigators observed knee motion that was more consistent with normal knee movement in patients with iTotal CR knee replacements compared to patients with off-the-shelf knee replacements. In addition, during a deep knee bend, patients with iTotal CR knee replacements achieved greater weight bearing flexion compared to patients with off-the-shelf knee replacements. In the second study, investigators analyzed 38 patients with total knee replacements. During a deep knee bend, 35% of patients with off-the-shelf knee replacements experienced implant lift-off in early flexion, whereas none (0%) of the patients with iTotal CR knee replacements experienced implant lift-off in early flexion. This difference was statistically significant. According to the investigators in this study, implant lift-off in early flexion is correlated with mid-flexion instability, a common source of patient dissatisfaction after knee replacement.
Additional studies presented at ICJR relating to customized ConforMIS iUni and iDuo partial knee replacements showed high patient satisfaction scores at two or more years post-surgery:
- In a prospective, single-arm, multicenter study, 118 patients with ConforMIS iUni knee replacements demonstrated improved range of motion and high functional scores at two years post-surgery, with 89% of patients stating that the movement of their knee felt natural.
- In a single-center study of 31 patients with ConforMIS iDuo customized implants, investigators found that a majority of patients rated their result as good or excellent, and 97% of patients reported that they would hypothetically undergo the same surgery again.
“Previous clinical studies have shown that about 20% of patients who receive a total knee replacement are not satisfied with the results. By focusing on the patient and specifically each patient’s unique anatomy, we believe ConforMIS is transforming the knee replacement experience for patients,” said Philipp Lang, MD, MBA, Chief Executive Officer and President of ConforMIS. “By designing implants to match the fit and natural curves of each patient’s knee, we believe our iTotal CR, iUni and iDuo knee replacements can provide patients with improved functional outcomes and higher overall satisfaction levels.”
About ConforMIS, Inc.
ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In recent clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. In addition, we believe ConforMIS implants provide economic advantages for hospitals by improving patient recovery times, reducing blood loss and reducing adverse event rates at discharge. ConforMIS owns or exclusively in-licenses approximately 470 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints. For more information, visit www.conformis.com.