Skip to main content

Table 4 Power calculation

From: A prospective multicenter phase I/II clinical trial to evaluate safety and efficacy of NOVOCART Disc plus autologous disc chondrocyte transplantation in the treatment of nucleotomized and degenerative lumbar disc to avoid secondary disease: study protocol for a randomized controlled trial

Treatment group mean / Treatment effect (contrast)

Width of two-sided 95 % confidence interval from point estimate to limit (units in standardized ODI)

Power of pairwise t-test to detect a difference in change from baseline of 10 units in ODI

 

ODI sum score (SD = 12 points)

Change in ODI (SD = 14.7 points = 12*sqrt (2(1-r))

when r = 0.25

Change in ODI (SD = 14.7 points = 12*sqrt (2(1-r))

when r = 0.25

SC (n = 24)

4.80

5.88

NDbasic (n = 36)

3.92

4.80

NDplus (n = 60)

3.04

3.72

NDbasic (n = 36) versus SC (n = 24)

6.20

7.59

71 %

NDplus (n = 60) versus SC (n = 24)

5.68

6.96

79 %

NDplus (n = 60) versus NDbasic (n = 36)

4.96

6.07

89 %