Description of the Data


List of Clinical Studies†


Study, as referred to by Medtronic

Number of Patients, rhBMP-2

Number of Patients, Control

INFUSE/LT-CAGE Pilot RCT

11

3

INFUSE/LT-CAGE Open Pivotal RCT

143

136

INFUSE/LT-CAGE Lap Pivotal Single-Arm

134

0

INFUSE/Bone Dowel Pilot RCT

24

22

INFUSE/Bone Dowel Pivotal RCT

55

30

INFUSE/INTER FIX PLIF RCT

34

33

INFUSE/CORNERSTONE ACDF Pilot RCT

18

15

INFUSE/Mastergraft Pilot RCT

25

21

INFUSE/INTER FIX ALIF Pilot RCT

25

20

MAVERICK Disc Pivotal RCT

172

405*

INFUSE/Telamon PEEK Instrumented PLIF Pilot, Single-Arm

30

0

rhBMP-2/BCP US Pilot RCT

22 (11 + 11)

5

rhBMP-2/BCP Canada Pivotal RCT

98

99

AMPLIFY Pivotal RCT

239

224

rhBMP-2/CRM 2-level Pilot, Single-Arm

29

0

rhBMP-2/BCP Mexico Pilot, Single-Arm

15 (8 + 7)

0

INFUSE/CORNERSTONE ACDF Pivotal

2

1

†All ClinicalTrials.gov Identifiers were determined by Yale University.
*In the MAVERICK study, the artificial disc was the investigational arm and LT-CAGE Lumbar Tapered Fusion Devise with INFUSE Bone Graft was the control treatment.