MEETING MINUTES

Meeting: Date:

DePuy One-Piece Metal-On-Metal IDE Clinical Investigators Meeting February 11, 2001

Location:

Attendees:

Vail Cascade Resort Vail, Colorado

Clinical Investigators

Andy Engh, M.D. David Fisher, M.D. Brian Haas, M.D. Doug Kilgus, M.D. James McAuley, M.D. David Pollock, M.D. Ray Wasielewski, M.D. Tom Schmalzried, M.D.

DePuy

Frank Chan Alan Cornell Andrew Ekdahl Steve Haas Jim Lancaster Deb Matarazzo Jorge Ochoa Barry Schneiders Leanne Turner Carleton Southworth Paul Voorhorst Steve Wentworth

This was the first clinical investigators meeting for the One-Piece Metal-on-Metal Hip IDE since patient accrual was initiated. Deb Matarazzo began the meeting by having all attendees introduce themselves. Dr. Haas made a few opening remarks and concluded that the early results for his IDE study cases looked very good, but that longer follow-up is required before any conclusions could be made. Dr. Engh concurred with Dr. Haas' comments with respect to his study cases.

Deb Matarazzo then presented the results reported to date. Copies ofDeb's slides are provided as Attachment 1. Deb stated that the follow-up compliance for the study patients is impressive and that the clinical investigators are to be commended for the fine effort put forth in following and reporting on their study patients. Deb also stated that the radiographic results were very limited due to technical problems with the Vidar x-ray scanner. The scanner is now back in service and she hopes to have the images sent to Dr. Engh for review and completion of the case report forms (CRFs) within a couple of weeks. Dr. Engh was impressed with the quality of the x-ray images that he had thus far reviewed, and he also said that he is very interested in seeing the radiographic results presented at the next investigators meeting.Dr. Engh stated that he is seeing very little heterotopic ossification in the x-rays that he has reviewed. Dr. Brian Haas stated that he is seeing calcar resportion at six months.

Dr. Schmalzried had a question on the metal/metal case with marked pain at 6 months, but this patient could not be identified as to whose case it was.

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Dr. Haas asked whether any ofthe investigators noted any separation between the femoral head and bearing insert on their radiographs. A lengthy discussion ensued regarding the occurrence and the ramifications of 'pistoning' with respect to wear of the metal/metal couple. More study of this issue is needed.

Dr. Haas discussed the issue of alignment of the acetabular components and emphasized to avoid aligning the cup too vertically. Assessing the degree of anteversion of metal/metal prostheses radiographically poses a particular problem. A lengthy discussion ensued as to how this might be accomplished, but there is apparently no consistently reproducible method for doing this at the present time. It was suggested that a review of abduction and adduction angles, as well as, radiographic results be reviewed at the next meeting.

Carleton Southworth discussed sample size requirements for randomized, controlled studies and explained how the test for non-inferiority was done. Paul Voorhorst discussed the differences between presenting clinical data for FDA review and for peer reviewed journal publications. Dr. Schmalzried commented that 'bad news' is easier to have published than is 'good news'. Dr. Engh commented that, if the follow-up up compliance can be maintained for the IDE study, then the results should be readily accepted for publication and this should help raise the standards for journal articles.

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Leanne Turner presented some of the results from the wear studies done for the one­piece, the Metasul® and the Ultima™ metal/metal designs. The one-piece design had the lowest volumetric wear of the 3 designs and this was attributed to the larger 36mm head size. Dr. Engh commented that he would like to see this information presented at the Orthopaedic Research Society and other venues. Copies of Leanne's presentation are provided as Attachment 2.

Dr. Schmalzried discussed the need for obtaining serum and urine ion levels for patients receiving these devices. He stated that this is still a major issue for metal/metal hips and that more information is needed for assessment of any associated risks. Dr. Schmalzried offered to work in collaboration with Dr. Josh Jacobs to collect and analyze these data for some of the IDE study patients. Dr. Schmalzried has developed a protocol and budget for serum and urine ion testing. He stated that the ideal patient is prospective and with no other implant. He suggested that at least twelve patients would be needed. Dr. Schmalzried went on to say that an autopsy of a patient with a 20 year old metal/metal hip showed no increase in metal ion concentration in that time. Dr. Brian Haas stated that there should be a control group. Dr. Schmalzried is to discuss this further with Jorge Ochoa.

Andrew Ekdahl presented the marketing strategy for DePuy metal/metal hips. He commented that 51 O(k)s for the Ultima and Pinnacle metal/metal cups have been cleared by FDA. A 51 O(k) for the one-piece cup will be submitted in May; however there are no plans to market the one-piece cup. Andrew urged the group to complete enrollment for the IDE as it will provide clinical data which will help with the marketing of the other designs. The investigators agreed to try and complete their cohorts, but admitted that

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once the 36mm Pinnacle Cup became available they would have a difficult time convincing their patients to enroll in the study. A copy of Andrew's presentation is provided as Attachment 3.

Dr. Haas asked Deb Matarazzo to send a letter to each investigator that specifies how many cases they have left, how fast they have been accruing cases, requesting that they complete their enrollment and whether they would be willing to accrue additional cases in order to complete study enrollment.

Dr. Haas and Dr. Engh stated that it is their intention to collaborate on a white paper when the 2 year study data becomes available.

Steve Wentworth gave a brief update as to the status of the petition to reclassify metal/metal hips that is pending at FDA.

Meeting adjourned,

Minutes prepared by,

S:~»V /;(/Q.,;;f;l~ Steven J. Wentworth Clinical Research Manager

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Attachments

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