August 12, 2019
Dear Kinamed Agents, Reps & Distributors,
We recently shared news about an exciting new study showing how CarboJet improves cement penetration in TKA – even when no tourniquet is used (see earlier email below or blog post on our sales portal here). This new study (which should help you sell more CarboJet), has now been officially published (view full study here), and we’re celebrating it with an official PRESS RELEASE (view here).
The study has also incorporated into some key sales support materials, including the Surgeon Request Letter – CarboJet; CarboJet Clinical Summary; Value Analysis Presentation –CarboJet, all available on www.kinamedportal.com. Our public website has been updated with links to the new study, and reprints have arrived (let us know if you want copies) and will be included in CarboJet pocket folders going forwards.
Some of our sales people have asked about the best way to interpret the results of this study and how to best utilize this study to sell more CarboJet. First of all, we’ve got to be clear about what the study compared. The 3 groups can be described as follows:
Group 1 “Tourniquet Only”: YES Tourniquet. NO CO2
Group 2 “CO2 Only”: NO Tourniquet. YES CO2
Group 3 “Tourniquet with CO2”: YES Tourniquet. YES CO2
Next, it is important to note that the study examined cement penetration in 7 different femoral and tibial zones – some with more cancellous bone than others. Zones without cancellous bone are naturally going to have less penetration – no matter how clean the bone gets. The focus should be on the cancellous bone zones, where the study found statistically significant improvements when CarboJet was utilized:
Below are the comparative results of Group 1 vs the two CarboJet Groups (Groups 2 and 3):
Tibial Zone 2 AP:
Group 2 vs Group 1 = 12.5% more penetration
Group 3 vs Group 1 = 17% more penetration
Femoral Zone 3A Lateral
Group 2 vs Group 1 = 15% more penetration
Group 3 vs Group 1 = 10% more penetration
Femoral Zone 3P Lateral
Group 2 vs Group 1 = 16% more penetration
Group 3 vs Group 1 = 14% more penetration
Tourniquet users should be interested in this comparison:
To determine the effect of CJ on cement penetration (when Tourniquet is used), compare Groups 3 and 1 (since both groups used a Tourniquet). The study found 10% to 17% more penetration in the zones that tend to have cancellous bone.
Those interested in tourniquet-free surgery should be interested in this comparison:
Compare Groups 2 and 1 (CJ was implemented to avoid compromising the cement mantle when tourniquet is dropped). The study found 12.5% to 16% more penetration in the zones that tend to have cancellous bone.
Key Quotes:
“Three radiographic zones (Tibial AP Zone 2, Femoral Lateral Zone 3A and Femoral Lateral Zone 3P) showed significantly more cement penetration for one of two groups that utilized the CO2 gas for bone preparation compared to tourniquet alone. These three zones tend to have less bone density and greater porosity of cancellous bone, as opposed to the frequently sclerotic medial tibial plateau in osteoarthritic varus knees, and therefore by using the CO2 gas as a bone preparation technique, cleared out more fat and debris to allow for enhanced cement penetration.”
“we report significantly greater cement penetration on the proximal tibia with the use of CO2 gas used for bone preparation compared to pulsatile lavage alone (Figure 3, 2.08mm vs. 2.43mm, p = 0.007)”
With results like this, it is truly an exciting time to be selling CarboJet! Please let me know if you have any questions, and stay tuned for news of additional studies that support the adoption of CarboJet!
Best Regards,
Joseph Larievy
Marketing Support Coordinator
Kinamed, Inc.
tel: 1-805-384-2748 x 213
fax: 1-805-384-2792
Confidentiality Notice: The information contained in this email, including any attachments, is intended only for the listed recipient(s) and may be privileged, confidential, and legally protected from disclosure. Dissemination, copying, or use of or reliance upon this email by or to anyone other than the listed recipient(s) is prohibited. If you are not the intended recipient, or if this email has been sent to you in error, please notify the sender immediately and destroy any and all copies of this email including any attachments.
From: Patrick Miller
Sent: Monday, April 22, 2019 8:07 AM
Cc: Roy Fiebiger <RFiebiger@kinamed.com>; Mark Distin <MDistin@kinamed.com>; Greg Lynch <GLynch@kinamed.com>; Richard Gerhart <RGerhart@kinamed.com>; rbruce@kinamed.com
Subject: NEW STUDY: Increased Cement Penetration with CarboJet in TKA and Tourniquetless TKA
Dear Agents, Reps and Distributors,
We are excited to announce the release of a new study: The Effect of Tourniquet Use and Sterile CO2 Gas Bone Preparation on Cement Penetration in Primary Total Knee Arthroplasty, by Meneghini et al, recently released as an “Accepted Manuscript” by the Journal of Arthroplasty (click links to view full study & Abstract).
Why is this study important and How will it help you sell more CarboJet?
Let’s start with the Conclusion:
“Bone prepared with CO2 gas showed significantly more cement penetration in three zones with greater cancellous bone. The results suggest use of CO2 gas bone preparation may achieve greater cement penetration than using a tourniquet with lavage only.”
In other words, not only does this reinforce our existing penetration study findings, but it shows that surgeons can achieve even better cement penetration in tourniquetless TKA than they had been achieving with the tourniquet by simply incorporating CarboJet into their routine. Most surgeons acknowledge the clinical downside to tourniquets, but have been reluctant to take the leap because of their concerns about a compromised cement technique.
Your job is to make sure those surgeons get their hands on this study and a CarboJet evaluation on their schedule ASAP!
Don’t we have studies that show this already?
Yes, there is the Goldstein study, which has been an excellent support piece, but can’t compare in terms of sample size, study design and release platform. This Meneghini study looked at 303 TKAs (the same cohort as his Opioid study), used patient x-rays to measure penetration, and is being published in a well-respected, widely-read peer reviewed journal.
Remind me again why Cement Penetration is Important?
Good question. You may have been told by surgeons that they aren’t concerned with cement penetration, since they “never have any problems with loosening”. Though we know that’s not true (Aseptic loosening is the number one cause of knee revisions), it is hard to sell a solution to a problem that the customer won’t acknowledge. That is where the science behind cement-bone behavior comes into play. Your surgeons may not acknowledge loosening, but they can’t argue that bone resorption occurs. And it’s logical to then state that more cement penetration will minimize the effect of bone-resorption. We’ll be sharing more information on this topic very soon, so stay tuned.
What is an “Accepted Manuscript”? Is this publicly available?
The full Meneghni Cement Penetration study is available to anyone for purchase or with a paid subscription to JOA. It has been “accepted for publication” meaning it will be fully published soon (likely in the next couple of months) with some formatting and copyediting. We will send out a press release when the study is fully published.
We encourage you to share news of the study with your surgeons right away, but please note that – because it isn’t free – the full study manuscript (and likely the final published study) may not be provided to surgeons without reporting the transfer of value per “Sunshine Act” requirements. For now, use the online abstract (available at this link), which includes instructions for obtaining the full study. When the study is fully published, we will be releasing and printing our own abstract of the study for inclusion in our CarboJet Pocket Folder brochure packets.
Please feel free to contact me with any questions. More information can be found at www.kinamedportal.com. And stay tuned for updates to sales support materials and Value Analysis presentations that incorporate this new clinical evidence…You don’t want to miss out on this wave of momentum that is inexorably pushing CarboJet towards becoming the “Standard of Care” in cemented arthroplasty!
Let’s Make it Happen!
Patrick Miller
Sales & Marketing Manager
Kinamed, Inc.
tel: 1-805-384-2748 x 207
fax: 1-805-384-2792
Confidentiality Notice: The information contained in this email, including any attachments, is intended only for the listed recipient(s) and may be privileged, confidential, and legally protected from disclosure. Dissemination, copying, or use of or reliance upon this email by or to anyone other than the listed recipient(s) is prohibited. If you are not the intended recipient, or if this email has been sent to you in error, please notify the sender immediately and destroy any and all copies of this email including any attachments.