Report for ANKLE DSMB: Prepared APRIL There have been 242 patients randomized online as of April 04, 2011.

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Wilfrid Houston
6 years ago
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1 Report for NKLE DSM: Prepared PRIL 2011 Part : Number of Patients Included and Excluded There have been 242 patients randomized online as of pril 04, Figure 1 presents the overall study status. Figure 2 shows the total number of enrolled patients by month. Table 1 presents the starting dates of recruitment of the centers in the study, and a month-bymonth picture of the recruitment each center has achieved. Part : Summary of Patient Randomization Table 2a presents the number of patients by treatment assignment. 120 patients have been randomized to Treatment (49.6%) and 122 to Treatment (50.41 %) Table 2b-c crossreferences each patient s online randomization with the treatment indicated on the Surgical Summary form. Of the 242 patients enrolled, 9 (crossed treatments) (3.71%). Part C: Patients lost to follow-up, withdrew consent, ineligible Table 3a presents the patients that were lost to follow-up, withdrew consent, or were removed due to an ineligible fracture. Table 3b-d shows the number of patients by center and fracture type that were lost to follow-up, withdrew consent, and were declared ineligible. There have been 37 patients lost to follow-up. 15 patients withdrew consent after randomization, 5 Patients were terminated by study team and 1 patient was removed due to an ineligible fracture pattern leaving a total active enrollment of 71. Part D: Summary of dverse Events Table 4a shows the event rates as of pril 04, There have been 27 reported dverse Events in 19 study patients, resulting in a () percent E rate in Treatment (N=120), and a (5.74) percent E rate for Treatment (N=122). There has been 1 Serious dverse Event reported. Descriptions of the reported dverse Events are presented in Table 4b. 1

2 Figure 1: Overall study status ctive N = 71 Overall Study Status Target N = 249 Randomized N = 242 Withdrawn N = 15 Terminated = 5 Enrolled N = 242 Inactive N =58 Lost to follow-up (N =37); Withdrawn Consent (N=15); Terminated (N=5); Died (N = 1) Completed N = 113 2

3 Jul- 08 ug- 08 Sep- 08 Oct- 08 Nov- 08 Dec- 08 Jan- Feb- Mar- Figure 2: Cumulative enrollment by month Enrollment by month from July 2008 to March pr- May- Jun- Jul- ug- Sep- Oct- Nov- Dec- Jan- Feb- Mar- pr- May- Jun- Jul- ug- Sep- Oct- Nov- Dec- Jan- 11 Feb- 11 Mar- 11 3

4 Table 1: Enrollment July 2008 through March 20 CenterID pproval Date Jul-08 ug-08 Sep-08 Oct-08 Nov-08 Dec-08 Jan- Feb- Mar- 01 -Sep Mar Jun Sep May Feb Jan Jun Jan May Total Sites Monthly Enrollment Cumulative Enrollment

5 Table 1: Enrollment pril 20 through October 20 Center ID pproval Date pril- May- June- July- ug- Sep- Oct- 01 -Sep Mar Jun Sep May Feb Jan Jun Jan May Total Sites Monthly Enrollment Cumulative Enrollment

6 Table 1: Enrollment through November 20 to May 20 Center ID pproval Date Nov- Dec- Jan- Feb- Mar- pr- May- 01 -Sep Mar Jun Sep May Feb Jan Jun Jan May Total Sites Monthly Enrollment Cumulative Enrollment

7 Table 1: Enrollment through Jun 20 to Dec 20 Center ID pproval Date Jun- Jul- ug- Sep- Oct- Nov- Dec- 01 -Sep Mar Jun Sep May Feb Jan Jun Jan May Total Sites Monthly Enrollment Cumulative Enrollment

8 Table 1: Enrollment through Jan 2011 to Mar 2011 Center ID pproval Date Jan-11 Feb-11 Mar Sep Mar Jun Sep May Feb Jan Jun Jan May Total Sites Monthly Enrollment Cumulative Enrollment

9 Table 2a: Enrollment by Treatment ssignment Center ID Treatment Treatment Total TOTL

10 Table 2b : Patients with different randomized treatment than indicated on surgical summary Subject ID Site Randomized Treatment Surgical Summary 03-*** *** *** *** *** *** *** *** Table 2c: Summary of patients that crossed treatment groups by Center Center Number of Patients Enrolled Crossed from to Crossed from to TOTL

11 Table 3a: Patients lost to follow-up, withdrew consent, ineligible Subject-ID Center- ID Date of Enrollment Date of Last Follow-up Reason 03-*** Sep Dec-08 Lost to f/u 03-*** Sep Jan- Lost to f/u 03-*** Nov Jan-20 Lost to f/u 03-*** Nov Dec-2008 Lost to f/u 03-*** Dec May-20 Lost to f/u 03-*** Dec-08 -Feb-20 Lost to f/u 03-*** Jan- 22-Jan- Lost to f/u 03-*** Jan- No follow up Lost to f/u 03-*** Jan- 29-Jan- Lost to f/u 03-*** Feb- 19-Mar- Lost to f/u 03-*** Feb- No follow up Lost to f/u 03-*** Feb- 19-Mar- Lost to f/u 03-*** Feb- 30-pr- Lost to f/u 03-*** Mar- 26-May- Lost to f/u 03-*** Jul ug-08 Lost to f/u 03-*** Jul Jan- Lost to f/u 03-*** Jul ug-08 Lost to f/u 03-*** ug-08 3-Feb- Lost to f/u 03-*** Jul- No F/u Withdrew Consent. 03-*** Feb- NO F/U Lost to f/u 03-*** pr- 29-pr- Terminated 03-*** Jul- NO F/U Withdrew Consent. 03-*** Jul-08 8-ug-08 Lost to f/u 03-*** Jul feb- Lost to f/u 03-*** Sep-08 -Oct-08 Lost to f/u 11

12 Subject-ID Center- ID Date of Enrollment Date of Last Follow-up Reason 03-*** Dec Mar- Lost to f/u 03-*** Jan- 07-pr- Lost to f/u 03-*** Feb- 16-pr- Lost to f/u 03-*** Mar- 30-Mar- Lost to f/u 03-*** Sep- 16-Feb- Lost to f/u 03-*** Sep-08 N/ Terminated 03-*** ug-08 No f/u Lost to f/u 03-*** ug Nov-08 Withdrew consent 03-*** Sep-08 8-Dec-08 Lost to f/u 03-*** Oct-08 6-Oct-08 Withdrew consent 03-*** Nov-08 No f/u Lost to f/u 03-*** Nov May- Withdrew consent 03-*** Dec Jan- Withdrew consent 03-*** Dec-08 9-Mar- Lost to f/u 03-*** Dec-08 -Jun- Withdrew consent 03-*** Dec-08 No f/u Withdrew consent 03-*** Dec-08 3-pr- lost to f/u 03-*** Jan- 2-pr- lost to f/u 03-*** Jan- 19-Mar- Withdrew consent 03-*** Jan- 2-Mar- Lost to f/u 03-*** Jan- 15-Jul- Withdrew consent 03-*** Feb- 31-Jul- Withdrew consent 03-*** Feb- No F/U in eligible 03-*** Feb- 28-May- Withdrew consent 03-*** Feb- 11-Jun- Withdrew consent 03-*** Feb- 7-May- Withdrew consent 03-*** May- No F/u Withdrew consent 12

13 Subject-ID Center- ID Date of Enrollment Date of Last Follow-up Reason 03-*** Jun- 12-Jun- Lost to f/u 03-*** pr- 2-Jun- Lost to f/u 03-*** Jan- 28-Jul- Lost to f/u 03-*** Oct- 9-Dec- Terminated 03-*** Oct- 7-Dec- Terminated 13

14 Table3b: Ineligible Patients by Table3c Withdrawn Patients by Fracture Type and Treatment ssignment Fracture Type and Treatment ssignment Treatment Treatment Treatment Treatment CenterID Total CenterID Total TOTL TOTL Table 3d: Patients Lost to Follow-up by Fracture Type and Treatment ssignment Treatment Treatment CenterID Total TOTL

15 Table 4a: dverse Event rates by treatment # Patients with Events Total Patients (Rate%) Treatment (.0) Treatment (5.74) Total (7.85) Table 4b: dverse Event descriptions Total Events = 26 Subject-ID Center ID 06-*** *** *** *** *** *** *** *** *** *** *** *** Treatment Date 05-Jul- 20-SEP- Description of Event PINFUL IMPLNT- SCREW,PLTE SUJECT EXPIRED DUE TO CNCER. 2-SEP- PINFUL IMPLNT-SCREW 2-SEP- DEVELOPED EQUINOUS CONTRCTURE 4-May- PINFUL IMPLNT-SCREW 9-Sep-08 SUPERFICIL INFECTION 30-Sep-08 DEEP INFECTION 6-Oct-08 DEEP INFECTION 30-Oct-08 SUPERFICIL INFECTION 9-Jul Jul-08 DVT 31-Jul-08 DVT Severity of Event SERIOUS MODERTE INFECTED SUPERFICIL WOUND (not at surgical site) MODERTE MODERTE Device Related? 15

16 03-*** *** *** *** *** *** *** *** *** *** *** *** *** *** *** Nov pr- 28-JUL- INFECTED SUPERFICIL WOUND (not at surgical site) CONTRUCT LOOSENING- DISTL TO FRCTURE SURGICL SITE/ORTHOPEDIC -Sep- INFECTION MINOR PTIENT REQUIRED LTERL PLTE WHEN 17-ug- RNDOMIZED TO NTIGLIDE 03-ug- PINFUL IMPLNT -PLTE 13-Sep-08 MYOCRDIL INFRCTION 20-Nov Feb- Non-Union FRCTURED OTHER NKLE (RIGHT) SERIOUS SERIOUS MODERTE MODERTE SEVERE 17-Feb- NECROSIS/WOUND SLOUGH 15-Sep- DEEP INFECTION 01-Jul- nterior Tendonitis 5-May- Neurological deficitperipheral injury 27-Feb-11 Necrosis/Wound Slough 14-Jul- Painful Implant-Screw MODERTE SERIOUS MODERTE PROLY PROLY 16

GAMINGRE 8/1/ of 7

GAMINGRE 8/1/ of 7 FYE 09/30/92 JULY 92 0.00 254,550.00 0.00 0 0 0 0 0 0 0 0 0 254,550.00 0.00 0.00 0.00 0.00 254,550.00 AUG 10,616,710.31 5,299.95 845,656.83 84,565.68 61,084.86 23,480.82 339,734.73 135,893.89 67,946.95