Skip to main content

Table 2 Exposure to the test product: dose administered

From: Safety of three different product doses in autologous chondrocyte implantation: results of a prospective, randomised, controlled trial

Dose group:

Low

Medium

High

All

N = 24

N = 25

N = 24

N = 73

Spheroids/cm2 based on defect area as found by arthroscopya

 Mean ± SD

10.8 ± 15.7

27.8 ± 13.0

40.5 ± 11.0

26.44 ± 17.9

 Median

7.0

28.8

41.80

28.2

 Range

6.8–84.0

11.3–83.1

11.6–59.8

6.8–84.0

Spheroids/cm2 based on defect area as found at implantationa

 Mean ± SD

7.6 ± 3.1

23.3 ± 6.7

37.7 ± 12.4

22.8 ± 14.8

 Median

7.0

24.7

40.7

23.4

 Range

4.7–21.0

9.3–30.7

11.6–59.8

4.7–59.8

Number of spheroids

 Mean ± SD

37.5 ± 10.8

128.1 ± 41.3

204.3 ± 51.4

123.3 ± 78.1

 Median

35

120

209

120

 Range

28–63

51–224

93–290

28–290

  1. aArea at arthroscopy was used for determination of dose (amount of chondrosphere®); area at implantation was post-debridement and therefore more accurate (see text)