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Table 1 Published clinical trials reporting outcomes of open tibial shaft fractures

From: A study protocol for a Pilot Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin versus Saline in Open Tibia Fractures (pGO-Tibia) in Dar es Salaam, Tanzania

Studies

Total sample

Open tibia sample

Number centers

Duration (years)

Enrolled/center

Enrolled/center/year

Follow-up rate

FLOW Trial [10]

2447

912

41

4

22

6

90%

SPRINT Trial [11]

1226

392

29

5

13

3

93%

MOI IMN v. Ex-fix [12]

240

240

1

1.3

240

180

92.1%

TRUST Trial [13]

501

114

43

4.5

3

< 1

96%

LEAP Study [14]

569

173

8

3

22

7

96%

INFINITI [15]

768

162

9

NR

18

NR

98%

Alberta Cohort [16]

791

140

3

8

47

6

94%

  1. Bold face text represents the previous randomized trial conducted by the coordinating center and MOI that enrolled and randomized 240 patients in 16 months