Month | Absence of meniscal extrusion | Presence of meniscal extrusion | |||||||||
Licofelone | Naproxen | p Value | Licefelone | Naproxen | p Value | ||||||
n | mm3/{%} | n | mm3/{%} | n | mm3/{%} | n | mm3/{%} | ||||
ITT | |||||||||||
Baseline | 93 | 5823.1 (1563.0) | 113 | 5696.2 (1746.5) | 0.587 | 54 | 5402.6 (1558.6) | 41 | 5301.0 (1225.3) | 0.732 | |
Change from baseline | |||||||||||
6 | 93 | −143.5 (126.7) | 113 | −163.7 (211.1) | 0.399 | 54 | −239.9 (184.9) | 41 | −293.8 (194.0) | 0.171 | |
{−2.6 (2.2)%} | {−2.8 (5.1)%} | 0.757 | {−4.6 (3.5)%} | {−5.9 (4.1)%} | 0.096 | ||||||
12 | 93 | −198.8 (152.1) | 113 | −253.7 (134.6) | 0.007 | 54 | −329.0 (208.5) | 41 | 423.9 (234.9) | 0.040 | |
{−3.7 (2.4)%} | {−4.6 (2.4)%} | 0.004 | {−6.2 (3.6)%} | {−8.2 (4.6)%} | 0.019 | ||||||
24 | 93 | −366.2 (192.8) | 113 | −437.2 (174.3) | 0.006 | 54 | −488.0 (267.3) | 41 | −615.2 (325.9) | 0.040 | |
{−6.5 (3.1)%} | {−7.8 (3.1)%} | 0.003 | {−9.1 (4.0)%} | {−11.7 (6.0)%} | 0.020 | ||||||
ATP | |||||||||||
Baseline | 42 | 5852.5 (1707.6) | 53 | 5958.7 (1702.6) | 0.764 | 40 | 5443.8 (1612.0) | 26 | 5005.9 (1065.1) | 0.189 | |
Change from baseline | |||||||||||
6 | 41 | −116.8 (155.4) | 53 | −163.5 (164.9) | 0.166 | 40 | −226.9 (190.3) | 26 | −272.4 (192.1) | 0.347 | |
{−2.0 (2.7)%} | {−2.9 (2.8)%} | 0.140 | {−4.4 (3.8)%} | {−5.8 (4.4)%} | 0.192 | ||||||
12 | 40 | −150.3 (218.8) | 53 | −219.1 (180.3) | 0.100 | 40 | −329.4 (225.6) | 26 | 430.5 (257.7) | 0.098 | |
{−2.6 (3.4)%} | {−3.8 (2.9)%} | 0.081 | {−6.1 (3.8)%} | {−8.6 (5.4)%} | 0.058 | ||||||
24 | 34 | −292.3 (305.5) | 50 | −398.3 (251.5) | 0.086 | 36 | −526.2 (317.4) | 23 | 644.8 (334.3) | 0.176 | |
{−5.0 (4.7)%} | {−6.8 (4.2)%} | 0.077 | {−9.8 (4.5)%} | {−13.1 (6.5)%} | 0.033 |
Results are shown as mean (SD) absolute (mm3) and {percentage ()%} changes of cartilage volume at 6, 12 and 24 months of follow up for the ITT and ATP populations for the medial compartment stratified by the absence or presence of severe meniscal extrusion.
p Values were assessed by two sample t tests.
ATP, according to protocol; ITT, intention to treat.