Table 2.
BiCRI (n = 47) | Microfracture (n = 45) | Treatment differencec (BiCRI − microfracture) | |
---|---|---|---|
Preoperative | |||
N | 47 | 45 | 0.54 (3.370d) |
Mean (SD) | 60.11 (15.488) | 59.64 (17.382) | |
(Min, Max) | (27.6, 96.6) | (19.5, 97.7) | |
P value | 0.8741a | ||
Week 6 | |||
N | 47 | 45 | |
Mean (SD) | 49.60 (11.236) | 51.83 (13.176) | |
(Min, max) | (28.7, 72.4) | (21.8, 88.5) | |
Mean change from baseline | |||
Mean (SD) | − 10.52 (16.657) | − 7.82 (17.510) | − 1.87 (2.371d) |
95% CI | − 15.407 to − 5.625 | − 13.077 to − 2.555 | − 6.584 to 2.842 |
P value | < 0.0001b | 0.0045b | 0.4321a |
Month 3 | |||
N | 47 | 45 | |
Mean (SD) | 64.29 (13.912) | 4.18 (18.173) | |
(Min, max) | (35.6, 89.7) | (33.3, 100.0) | |
Mean change from baseline | |||
Mean (SD) | 4.18 (18.173) | 7.20 (19.679) | − 1.96 (2.586d) |
95% CI | − 1.154 to 9.518 | 1.291 to 13.115 | − 7.096 to 3.184 |
P value | 0.12b | 0.02b | 0.45a |
Month 6 | |||
N | 47 | 45 | |
Mean (SD) | 75.62 (13.357) | 75.25 (16.358) | |
(Min, max) | (43.7, 100.0) | (25.3, 100.0) | |
Mean change from baseline | |||
Mean (SD) | 15.51 (19.421) | 15.61 (22.887) | 0.79 (2.694d) |
95% CI | 9.803 to 21.207 | 8.731 to 22.483 | −4.567 to 6.146 |
P value | < 0.0001b | < 0.0001b | 0.77a |
Month 12 | |||
N | 46 | 45 | |
Mean (SD) | 85.61 (16.960) | 87.15 (15.980) | |
(Min, max) | (43.7, 100.0) | (35.6, 100.0) | |
Mean change from baseline | |||
Mean (SD) | 25.56 (18.476) | 27.51 (23.651) | − 1.61 (2.684d) |
95% CI | 20.076 to 31.049 | 20.404 to 34.615 | − 6.950 to 3.721 |
P value | < 0.0001b | < 0.0001b | 0.55a |
End of study | |||
N | 47 | 45 | |
Mean (SD) | 85.33 (16.885) | 87.15 (15.980) | |
(Min, max) | (43.7, 100.0) | (35.6, 100.0) | |
Mean change from baseline | |||
Mean (SD) | 25.21 (18.429) | 27.51 (23.651) | − 1.56 (2.652d) |
95% CI | 19.803 to 30.625 | 20.404 to 34.615 | − 6.835 to 3.708 |
P value | < 0.0001b | < 0.0001b | 0.56a |
aInter-group P value from the ANCOVA model (outcome = treatment + site + error) for the preoperative visit.
Model for mean change value: outcome = treatment + site + baseline + error. P value is from testing the difference in treatment effect between study groups
bIntra-group P value from the paired t-test
cLeast squares estimation
dFor the treatment difference column, the mean (with the standard errer in parentheses) is shown