New Study Shows Use of Kinamed’s CarboJet® System Yields Increased Bone Cement Penetration in Total Knee Arthroplasty, Even When No Tourniquet Is Used
August 7, 2019
Camarillo, California – A new clinical study published in the Journal of Arthroplasty demonstrates that use of the CarboJet CO2 Bone Preparation System from Kinamed Incorporated yields increased bone cement penetration in total knee arthroplasty (TKA), even during tourniquetless surgery in which a thigh tourniquet was not used to control bleeding at any time during the procedure.
As stated in the study, “Tourniquetless TKA is experiencing resurgence in popularity due to potential pain control benefits. Furthermore, optimal cement technique and implant fixation remain paramount to long-term cemented TKA success, as aseptic loosening continues to be a leading cause of revision.” The study notes that aseptic loosening remains one of the primary causes for early and late revisions, with up to 28.7% of all revisions being due to aseptic loosening.
The study authors also note that “Increasing the amount of cement into the tibial and femoral bone (cement penetration) has been shown to provide a stronger bone-cement interface which leads to increased stability and long-term survivorship of the implants.” Achieving appropriate penetration and inter-digitation of bone cement is therefore important for ensuring the overall success of TKA.
This new study, performed by R. Michael Meneghini M.D. and colleagues at the Indiana University School of Medicine, compared cement penetration in three groups of TKA patients: (1) tourniquet without CO2 gas bone preparation, (2) no tourniquet with CO2 gas bone preparation, and (3) tourniquet with CO2 gas bone preparation. The results show that when sterile compressed CO2 gas is used for bone preparation, cement penetration is actually increased in not only the tourniquet (group 3) but also in the no-tourniquet group (group 2), as compared to the tourniquet group in which CO2 gas was not used (group 1).
An earlier study conducted by Dr. Meneghini and colleagues compared TKA groups with and without use of the thigh tourniquet and demonstrated that female patients in the no-tourniquet group experienced significantly less post-operative pain and consumed fewer opioids as compared to female patients in the tourniquet group. Their work has important implications given the scope of the opioid crisis and the very large number of knee replacements being performed in the United States.
About Kinamed
Kinamed is a leading developer, manufacturer, and distributor of innovative specialty orthopedic, neurosurgical, and cardiothoracic medical devices. In addition to the CarboJet system, Kinamed’s other orthopedic products include: the SuperCable® Iso-Elastic Polymer Cerclage system: a revolutionary cabling system that eliminates problems associated with traditional metal cables; and the KineMatch® Patello-Femoral Replacement: a patient–specific (custom) unicompartmental joint replacement implant. Since the company’s founding, Kinamed has manufactured and sold over 2.5 million surgical implants.
For additional information on Kinamed, Inc., please visit www.Kinamed.com.
Dr. Meneghini is a consultant for Kinamed.
CarboJet® Employed in Study Showing Tourniquetless Total Knee Arthroplasty Decreases Pain and Opioid Consumption in Women
Given the opioid crisis in America, surgical protocols that minimize opioid consumption are highly sought after. A recently published study shows that elimination of the tourniquet during TKA may be one such protocol.
CAMARILLO, CALIF. (PRWEB) DECEMBER 11, 2018
A new clinical study published in the Journal of Arthroplasty comparing total knee replacement (TKR) surgery with and without use of the traditional thigh tourniquet demonstrated that female patients in the no-tourniquet group experienced significantly less post-operative pain and consumed fewer opioids as compared to female patients in the tourniquet group.
In 2017, there were approximately 50,000 opioid drug overdose deaths in the United States. Although opioids are effective at reducing pain after surgery, patients receiving prescription opioids are at risk for developing an opioid use disorder. Therefore, development of surgical protocols that reduce post-operative pain and the need for opioid medication are of critical importance and are highly sought after.
Maintaining appropriate penetration and inter-digitation of bone cement is extremely important for ensuring long-term success of TKR, because aseptic implant loosening has been identified as a leading failure mode in the modern TKA procedure. When performing knee arthroplasty without a tourniquet, achieving an optimal “cement technique” can be a challenge because of the additional fluid debris present in the bone and at the implant-interfaces. The CarboJet® CO2 Bone Preparation system employed in this study addresses this challenge by using medical-grade compressed carbon dioxide gas to remove lipids/fatty marrow elements, blood, and saline from the bone surface prior to the application of bone cement. The lead author of this study, R. Michael Meneghini, MD, Associate Professor of Clinical Orthopedic Surgery at Indiana University School of Medicine, chose to employ the CarboJet system to manage these blood and lipid debris and optimize cement penetration for his patients.
With nearly 800,000 procedures performed in the United States each year, knee replacement surgery is one of the most widely accepted and effective treatments for relieving the pain and disability associated with degenerative osteoarthritis. Because of the sheer number of knee replacements being performed, approaches that can reduce opioid consumption as demonstrated in this study are noteworthy.
About Kinamed
Kinamed is a leading developer, manufacturer, and distributor of innovative specialty orthopedic, neurosurgical, and cardiothoracicmedical devices. In addition to the CarboJet system, Kinamed’s other orthopedic products include: the SuperCable® Iso-Elastic Polymer Cerclage system: a revolutionary cabling system that eliminates problems associated with traditional metal cables; and the KineMatch® Patello-Femoral Replacement: a patient–specific (custom) unicompartmental joint replacement implant. Since the company’s founding, Kinamed has manufactured and sold over 2.5 million surgical implants.
For additional information on Kinamed, Inc., please visit www.Kinamed.com. The full press release can be viewed here.
Dr. Meneghini is a consultant for Kinamed.
Kinamed Receives Japan Ministry of Health Approval for SuperCable®
Kinamed begins SuperCable distribution in Japan with Yufu Itonaga Co., Ltd.
Camarillo, CA June 5, 2014 – Kinamed Inc. announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) granted regulatory clearance for Kinamed’s SuperCable® Iso-elastic, Polymer Cerclage System. MHLW clearance enables Kinamed to begin SuperCable commercialization in Japan through its longtime Japanese distribution partner, Yufu Itonaga Co., Ltd. of Tokyo. The SuperCable System is used in a wide range of orthopedic reconstructive and trauma applications, and it is the only iso-elastic, polymer cerclage system on the market anywhere in the world.
Bob Bruce, Kinamed’s Vice President of Global Sales and Marketing notes that, “The SuperCable polymer cerclage system has been in clinical use in the United States for ten years and has enjoyed tremendous growth as orthopedic surgeons have become focused on issues of metal debris generation and corrosion from metal/metal interfaces in orthopedic implants.” Traditional metal cerclage cables are made up of many tiny braided metal wire filaments that, by the very nature of their construction, result in a large number of metal on metal wear interfaces. According to Mr. Bruce, “the polymer construction of the SuperCable eliminates the potential for such metal particle generation while also offering improved fatigue strength, and an engineered elasticity that allows the cable to flex with dynamically loaded bone.”
Mr. Hironori Sagawa, Yufu Itonaga Surgitec Division Director, commented, “I am very pleased that our company can now offer such a unique and innovative cerclage system to the Japanese orthopedic community. It is exciting to be able to offer a product that has such significant clinical benefits versus older technologies and that also offers important synergies in our product portfolio.” Yufu also represents two other Kinamed product lines in Japan: the CarboJet® CO2 Lavage System used for cleaning and drying the bone bed in cemented arthroplasty procedures and the NeuroPro® Cranial Fixation System used by neurosurgeons for cranial closure.
“We are very appreciative of our very longstanding relationship with Yufu Itonaga and particularly for the work they have done in obtaining the Japanese regulatory approval for SuperCable”, stated Vineet Sarin PhD, Kinamed’s President. According to Dr. Sarin, “Commercializing SuperCable into the Japanese orthopedic market is a major milestone for Kinamed.”
About Kinamed
Kinamed offers unique and clinically proven products in the orthopedic reconstructive and neurosurgical products space. A true innovator, the company utilizes proprietary technologies to develop, manufacture and commercialize products that solve significant unmet clinical challenges. The company’s portfolio includes the SuperCable® Polymer Cerclage System and associated cable-plates and trochanteric grips; the CarboJet® CO2 Bone Lavage System; the KineMatch® Patello-Femoral Replacement, a CT based custom arthroplasty technology; the NaviPro® Surgical Navigation System, and the NeuroPro® Cranial Plating System.
For further information please contact Bob Bruce at rbruce@kinamed.com
Kinamed, Inc. Licenses Computer Assisted Surgical Navigation Technology
Kinamed, Inc. licenses patented reliability verification technology to Blue Belt Technologies Camarillo, CA (PRWEB) February 07, 2013 — Kinamed Incorporated, an innovative medical device company whose focus includes technology for computer assisted orthopaedic surgery, today announced that it has agreed to non-exclusively license its patent 6,711,431 to Blue Belt Technologies, Inc. The patent covers an intraoperative method of verifying the reliability of a computer assisted surgical navigation procedure.
“This patent fundamentally covers the ‘verification point’ concept – the method of checking and confirming, during surgery, the reliability and accuracy of a computer assisted navigation procedure that is performed with optically tracked passive, semi-active, or active robotic tools,” said Clyde R. Pratt, Chairman and CEO, Kinamed Incorporated. “We are pleased to license this patent to Blue Belt Technologies, a recognized leader in the field of surgical navigation and precision robotics,” he said.
Blue Belt’s NavioPFS orthopaedic surgical system incorporates patented technology to provide precision to surgeons via smart instrumentation with robotic control. The NavioPFS, for use in unicompartmental knee replacement (UKR) surgery, received the CE Mark in February 2012 and 510(k) clearance from the U.S. Food and Drug Administration (FDA) in November 2012. The system is being used clinically in both Europe and the United States where the system has produced excellent early clinical results. Terms were not disclosed.
Blue Belt Technologies, Inc.
Blue Belt Technologies, Inc. is developing the next generation of “smart” surgical instruments with precision robotics for use initially in orthopedic procedures and then for other surgical specialties, including neurosurgery, spinal and otolaryngology (ENT). The company’s NavioPFS System incorporates patented technology to provide precise robotic control to surgeons via an intelligent, handheld, computer-assisted bonecutting tool. The NavioPFS System provides the surgeon with a layer of safety and enhanced accuracy while performing bone-shaping tasks through minimally invasive incisions.
CONTACT: Eric B. Timko (412-683-3844 or etimko@bluebelttech.com). www.bluebelttech.com
Kinamed Incorporated
Kinamed Incorporated designs and manufactures implantables and instruments for orthopedics and neurosurgery. Kinamed’s technology portfolio includes the SuperCable polymer cerclage cabling system, the CarboJet carbon dioxide lavage system, the KineMatch patient-specific patello-femoral replacement system, the NeuroPro rigid cranial fixation system, and the NaviPro surgical navigation system.
CONTACT: Vineet K. Sarin, Ph.D. (805-384-2748 or vsarin@kinamed.com).
New Study Reports Unparalleled Clinical Results for Treatment of Anterior Knee Arthritis
In a recent issue of The Journal of Bone & Joint Surgery (JBJS), unparalleled surgical outcomes were reported when using Kinamed’s FDA-cleared KineMatch® Patello-Femoral Replacement device which replaces just one part of the knee unlike “total knee replacements” that replace all three compartments of the knee.
Camarillo, CA (PRWEB) December 4, 2007 — In a recent issue of The Journal of Bone & Joint Surgery (JBJS), unparalleled surgical outcomes were reported when using Kinamed’s FDA-cleared KineMatch® Patello-Femoral Replacement device which replaces just one part of the knee unlike “total knee replacements” that replace all three compartments of the knee. Twenty-five (25) consecutive knees were treated with the KineMatch device. At an average follow-up period of 73 months (6+ Years following surgery) all 25 implants were in place and functioning well. There were 18 “Excellent” and 7 “Good” results using the Knee Society scoring method. No patient had required additional surgery or had component loosening.
According to the study’s lead author and primary surgeon (Domenick J. Sisto, MD, Los Angeles Orthopaedic Institute, Sherman Oaks, CA), “the KineMatch device has offered a remarkable benefit and return to function for our patients with intractable patello-femoral disease who were otherwise facing the prospect of total knee replacement or patella removal.” Dr. Sisto continued, “the KineMatch device is a conservative approach that is appropriate on a unique subset of patients who would otherwise be candidates for more extensive total knee replacement. Another benefit to the KineMatch device is our ability to convert it to a total knee replacement should that become necessary in the future.”
Women comprise approximately 75% of patello-femoral arthroplasty patients, due to patello-femoral malalignment and dysplasia which is much more common in women than in men. The problem can also be the result of sports or work-related wear and tear. Pain associated with patello-femoral arthritis is directly under the knee cap and is most severe when using stairs, prolonged walking, walking up hills, squatting and kneeling. The pain is less severe when walking on level surfaces. When sitting, patients with patello-femoral arthritis are more comfortable with their knee straight rather than bent. The typical patient is relatively young when compared to the total knee replacement candidate – in this study the average patient was 45 years old and had one or more prior surgical procedures that attempted to treat their knee pain.
The KineMatch Patello-Femoral Replacement device begins with a computed tomography (CT) exam of the patient’s knee. The CT data is used to manufacture the KineMatch device, which is custom made for each patient. This is believed to be key to obtaining good clinical results while also offering a very conservative “bone sparing” approach for the younger patient. The surgical procedure itself is also shortened because little bone sculpting is required to implant the device and the recovery time and post-operative rehabilitation time is reduced as compared to what is required after total knee replacement. The cost of the KineMatch device is less than the cost of a typical “high-performance” total knee replacement device and the operative time and recovery period are also less than what one would experience with total knee replacement.
About Kinamed
Established in 1987, Kinamed is a privately held medical device company based in Camarillo, California. Kinamed designs and manufactures implants and instruments for orthopedics and neurosurgery.