Table 2.
Exposure to the test product: dose administered
| 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 |
aArea at arthroscopy was used for determination of dose (amount of chondrosphere®); area at implantation was post-debridement and therefore more accurate (see text)