The Rover

♦ Please welcome newly IRB approved surgeon: Tal David ♦ Time is running out for new surgeons who need to get

IRB approval. Enrollment of new sites will be closed 1/1/09.

♦ Newsletters will be archived on the AOSSM web site: http://www.sportsmed.org/tabs/research/mars.aspx ♦ Congratulations to the following surgeons for enrolling

their first study subject: Keith Baumgarten and Rudolf Hoellrich.

♦ MARS Coordinator Conference Call Minutes are attached

to this newsletter. Comet Hale-Bopp passes over a rural Rice County, Kan., windmill, just north of Hutchinson, Kan., on Thurday, March 27, 1997. (NASA)

What’s New? Volume 1 (4) October 6, 2008

Reminders ⇒ Coordinators will be e-mailed up-

dated case report forms and other materials discussed during the conference call.

⇒ New IRB approved surgeons

please forward a copy of your up-dated CV to haasa@wudosis.wustl.edu so that it may be formatted to a NIH bios-ketch for the MARS grant.

⇒ New surgeons need to make sure

they have turned in the following PRIOR to enrolling your first pa-tient:

IRB Approval Letter Surgeon Agreement Letter Practice Surgeon Form Meniscal Inter-Rater Forms

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Questions or Comments? E-mail us at haasa@wudosis.wustl.edu or call (314) 362-3768

♦ We are currently re-working the MARS NIH grant. We will be resubmitting in November.

Upcoming Events 

Bridger Orthopaedics IRB– Expires 10/24/08

Tennessee Orthopaedic Alliance IRB– Expires 11/8/08

COR-Arlington, VA IRB– Expires 11/14/08

Inland Orthopaedics IRB– Expires 11/29/08

Methodist Hospital IRB—Expires 12/13/08

Need New IRB Approval Letters From: Case Western

University of Pittsburgh

Upcoming IRB Renewals   

Top Ten List Name Number Enrolled 1) Chris Kaeding 2) Dan Cooper 3) Rick Wright 4) Kurt Spindler 5) David McAllister 6) Rick Parker 7) Tom DeBerardino 8) Brick Lantz 9) Matt Matava 10) Christina Allen* 11) John Campbell*^

Ties are listed in alphabetical order* Eleven listed due to tie^ Totals are as of 9/26/08

29 26 21 19 17 15 13 12 10 9 9

Congratulations to Dr. Chris Kaeding and his study coordi-nator Angela Pedroza from The Ohio State University for enrolling the most patients (n=5) this month.

Martians of the Month

Questions or Comments? E-mail us at haasa@wudosis.wustl.edu or call (314) 362-3768

Related to last week: (Example to the left) Surgeon Form Tidbit If a page is irrelevant and you do not need to com-plete (i.e. the primary ACL section, pages 15-17, or some of the meniscal or AC pathology pages), please avoid crossing out that section/page with a pen or pencil. Reason: The scanning software will pick up ANY line that crosses a box, and erroneously treats it as a popu-lated answer. Solution: Put a post-it note on that page to remind you that you don’t need to fill out a particular page, based on the patient’s knee pathology.

Packet Completion Issues 

Enrollers of the Month Congratulations to the following Surgeons and Coordinators for Submitting a patient this month (as of 9/26/08): Surgeon Coordinator(s) Site Keith Baumgarten Kari Caspers Orthopaedic Institute Dan Cooper Donna Stewart WB Carrell Memorial Clinic Tom DeBerardino Jennifer Chu Jones/ Ken Cameron West Point David Flanigan Angela Pedroza The Ohio State University Sharon Hame UCLA Rudolf Hoellrich Crystal Mills Slocum Center for Orthopaedics Chris Kaeding Angela Pedroza The Ohio State University Bruce Levy Angela Barraza Mayo Clinic Robert Marx Patrick Grimm HSS Eric McCarty Paula Langer University of Colorado Ali Motamedi Cathy Harris-Gorzadek UCLA James Slauterbeck Marlene Booth University of Vermont Kurt Spindler Laura Huston Vanderbilt University Michael Stuart Angela Barraza Mayo Clinic Rick Wright Amanda Haas/ Linda Burnworth Washington University-St. Louis

Thank you to the following Coordinators for participating in the MARS Coordinator Conference calls that were held 9/24/08 and 9/25/08. MARS would not run as smoothly as it does without each and every one of you! Coordinator Site Mukesh Ahjua RUSH Carla Britton University of Iowa Debra Brovelli Orthopaedic and Fracture Clinic Kari Caspers Orthopaedic Institute Laura Miele-Conlon Elite Sports Medicine Sharon Griffin Fowler Kennedy Patrick Grimm HSS Laura Huston Vanderbilt University Jennifer Chu Jones West Point Theresa Kijek University of Michigan Paula Langer University of Colorado Robin Leger University of Connecticut Hemang Panchel University of Michigan Tom Ross Manhattan Orthopedics Brian Pahk NYU Justin Shaginaw University of Pennsylvania Mauri Zomar University of British Columbia

Thank‐You! 

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MARS Coordinators Conference Call Minutes

(9/24/08 and 9/25/08)

Roles of Vanderbilt and Wash U ♦ Vanderbilt is considered the data coordinating center, and their responsibilities include:

⇒ Generating and sending out packets to sites ⇒ Receiving all packets from sites (including the xrays) ⇒ Entering the data into the database ⇒ Data cleaning and analyzing ⇒ Sending out the $20 subject reimbursement checks to the patients (for sites that don’t de-identify their subjects)

♦ Wash U’s responsibilities encompass: ⇒ Getting new sites up and running ⇒ All items related to IRBs ⇒ All patient follow-up

MTF graft Issues No sites represented in the conference calls expressed trouble in getting allografts from MTF. However, in the past, we’ve had 3 sites contact Vanderbilt/Wash U/AOSSM about the inability to procure a graft for a MARS patient. This was discussed at the MARS meeting in February at AAOS. If a site has trouble, they’re instructed to call either Vanderbilt or Wash U and alert them of the issue. We’ll attempt to work with MTF to try to get a graft to your site. Unfortunately, in the past, MTF has not been as helpful as we would have liked. One possible solution to prevent this would be to ask each site’s hospital to keep an extra MTF graft in their freezer, so that it could be used as a back-up. We understand that sites are bound by their hospital facilities poli-cies (or budgetary constraints), and that this may not be feasible. However, for some sites, this may remedy the situation. If we come up with more viable alternatives, we’ll pass them along to the group. Conversely, if sites have found success with a certain method, please let us know as we’d be happy to share them with the group. Data Packets

• Should be sent to Laura Huston @ Vanderbilt.

• Sites should keep the original consent, and send Vanderbilt a copy. This original consent should be kept on file at the site, in accordance to their IRB’s policies.

• Originals of the patient questionnaire and surgeon questionnaire should be sent to Vanderbilt. The reasoning behind

this is because these forms are scanned into a software program that dumps the data into a database. This software program is sensitive to page misalignment – the kind you see when a Xeroxed page isn’t quite the same as your origi-nal. If Vanderbilt receives a copy, they’re forced to hand enter the data into the database, which is a much slower process.

• All items that need to be sent to Vanderbilt are on Item #5 on the Case Report Form (the checklist).

• The Case Report Form lists the xray views that were taken for the patient. There are 2 minimum required views -- 1)

Bilateral standing AP, and 2) Full extension lateral. Amanda/Laurie will revise the Case Report Form and put an as-terisk on these views, denoting their importance. The other views are optional. Amanda will also email example views of each of these, so that the ‘layman’ knows which view is what. However, it may be easier to have your PI check these off.

Of note – because we’re only collecting standard of care xrays, you only need to send the xray views that your PI re-quested at the time of the patient’s clinic visit. If your physician did not order a “bilateral standing AP” or “full extension lateral”, then you do not need to specially order them to fulfill these study requirements. Similarly, if your PI did not obtain any xrays at the time of the patient’s clinic visit, you should just write a note on the case report form, explaining as such. If the patient brings in outside clinic xrays at the time of their visit, and you are willing to duplicate and send us these cop-ies, then we welcome and are appreciative of that. • XRays can be sent either by CD (our preference), hard copy, jpg printouts, or via email (to Laura Huston). If sites pre-

fer hard copy, they are welcome to put the rest of the packet in with the large xray mailing sleeve, so that all required documents arrive in one shipment. 

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Wanting More Information from Question #33 on the Surgeon Form On page 18 of the surgeon form (question #33), the question reads, “Surgeon’s Opinion on Cause of Failure”. This is proving to be an interesting question that may lead to determining the predictors of primary ACL failures (and what could help decrease their incidence). The preliminary data looks like there are a fair number of surgeons who chose “Combination of Above” as an answer to this question. However, we would like to know that components made up that reasoning. Was it “traumatic” plus “technical error from prior surgery”, or “biologic failure to heal” plus “traumatic”, or all three. The original forms that were sent to the early sites did not instruct the physician to “CHECK ALL THAT APPLY”. Later versions of the surgeon forms included this instruction relating to this question. The most recent version of the surgeon form actually has “Combination of Above” erased, which will force the physician to choose all the components that they believed were con-tributing factors in the failure of the ACL graft. We’re requesting 2 things from the coordinators: a. Before you send in a packet, could you check page 18, question #33, to see what your physician marked. If they checked

“combination” without its components, could you ask them to also check the items they think made up that “combination” an-swer?

b. For older forms that were submitted to Vanderbilt in which “combination of above” was the only answer checked, we wanted to give a heads up to you that Laurie Huston will be sending you a copy of this form (along with the front page of the surgeon form, so that you can pull their medical record), either by mail or email. In this mail/email notice, she’ll include the instructions to the physicians on what to do. It will require them to pull the patient’s medical record and check the components of this ques-tion that they believe make up ‘combination’. When completed, these forms should be faxed back to Vanderbilt (fax #615-322-7126). Expanding Patient Follow-up At the beginning of this endeavor, the initial protocol was to follow up patients at 2 years post surgery. At the time, we did not know if this study would make it off the ground, as well as not knowing the funding status. From AOSSM’s perspective, this study has exceeded their expectations (79 surgeons are currently IRB approved; n=308 sub-jects enrolled). This has allowed us to put together a NIH grant application to ask for future funding for the MARS Study. So plans have changed. As such, we’d like to expand our length of patient follow-up to include 6 and 10 years, in addition to our existing 2 year time point. What it means to sites: For the older MARS sites, we will ask you to re-submit a revised protocol and consent form at the time of your yearly annual IRB review. This minimizes your administrative burden, and for sites that are required to pay for each amendment submitted, this reduces their cost. Amanda will distribute a revised Study Protocol via email to everyone, and will work with sites at the time of their renewal to ensure that your consent form has the necessary language. For newer sites (and for sites that are also in the MOON consortium) – this should already be in your protocol, but please check. Of note – Subject reimbursement will also follow suit. Subjects will receive $20 each time they are asked to fill out a question-naire. So their total compensation will increase from $40 (index and 2 year follow-up) to $80 (index, 2, 6, and 10 year follow-up). MARS Conference Calls We’d like to get feedback from the sites as to whether or not they believe periodic conference calls are beneficial. The purpose of these calls would be to supplement email and newsletter items and disseminate information to sites that would be best served over the phone. In addition, these calls would serve as both a feedback tool as well a forum for discussion for items that needed clarification. Amanda and Laurie thought that if there was interest in continuing these conference calls, that it would perhaps occur on a quarterly basis. Please email Amanda as to your thoughts on this.

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Misc. Items • Per request, a copy of the most common Surgeon Errors List will be emailed to everyone. • Coordinators wished to improved the following items in the Surgeon form:

♦ Page 4, question #14a. “Generalized Laxity” is in all caps, where 14b-d items are not. A request was made to make the headings of question #14a-d the same.

♦ Action item: This correction has been made, so that all subsequent forms that go out from Vanderbilt will now have this change incorporated in the surgeon form.

♦ Page 18, question #33. A request was made to add a line after the choice, “Other”, so that people could write in

their particular reason and provide more detail. ♦ Action item: this answer has now been changed in subsequent forms that go out, as it will now include a line af-

ter “other”. For those sites who check ‘other’, feel free to write down the reason somewhere near question #33. ♦ Page 18, question #35. The choice “Malalignment (in any plane)” is confusing. A request was made to clarify

this answer. ♦ Action item: this answer refers to limb or knee malignment, as seen with varus or valgus knees. The answer

has now been changed in subsequent forms that go out, as it will now read “Knee malalignment (ie. varus or val-gus)”.

Note: Upon discussion, it was agreed upon that “Malalignment” wasn’t really a technical error, but should really have been listed in question #33. We agree, but that change would alter the form and database, so that existing forms that have already been printed would have to be hand-entered upon arrival at Vanderbilt. So even though this change is simple on the front end, it would involve too much work on the back end to incorporate this legitimate request.

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