HUGHSTON SPORTS MEDICINE CENTER

INSTITUTIONAL REVIEW BOARD

March 2, 2017

PRELIMINARY AGENDA

 

I.     Call to Order and Reading of Minutes

II.     Old Business

A.     Medtronic Prestige LP PAS                                                                            J. Kenneth Burkus, M.D.

                 Patient Transfer from Emory

                 Sponsor’s 12-Month Report to FDA

B.     PEEK Interbody Fusion Device Through XLIF Approach                      J. Kenneth Burkus, M.D.

                 Progress Report – Reapproval Request                   

C.     Medtronic InFuse/Mastergraft for Posterior Fusion                              J. Kenneth Burkus, M.D.

                 Letter from Medtronic re: Investigator & Payment Status

      D.     Spinal Kinetics M6-C Artificial Disc                                                          J. Kenneth Burkus, M.D.

                 Dr. Burkus not participating

      E.     AOSSM Multi-Center ACL Revision (MARS) Study                               Champ L. Baker III, M.D.

                 Progress Report – Reapproval Request

      F.     Greater Tuberosity Notch Study                                                                 Champ L. Baker, Jr., M.D.

                 Re-open Study for New Data Analysis                                                   Champ L. Baker III, M.D.

G.     Subpectoral Biceps Tenodesis After Biceps Rupture                               Champ L. Baker III, M.D.

                 Progress Report – Reapproval Request

H.     Patient Height as Risk Factor for Disloc in Posterior THA                    Timothy Beals, D.O.

                 Progress Report – Reapproval Request

III.     New Business

A.     AO Spine DegenPRO Spine Registry                                                            William E. Neway III, D.O.

                 Approval Request

IV.     Other Business

A.     IRB Member Training

                 January 2017 Revision to the Common Rule

                Summary of Changes

B.     Schedule June 2017 Meeting

V.     Adjourn