Table 5: Changes in clinical and radiographic parameters over time.
Month Group |
M0 (Baseline) |
M12 |
M24 |
M36 |
M48 |
M60 |
M72 |
M84 |
M96 |
NS |
|
||||||||
K/L-II’H’† |
|
THR-M85 (M84-M86) |
|
||||||
PW-VAS |
41 (39-42) |
43 (41-45) |
47 (46-48) |
51 (50-52) |
55 (54-56) |
59 (58-60) |
65 (64-66) |
74 (73-75) |
|
WOMAC-C |
32 (31-33) |
34 (31-36) |
37 (36-38) |
41 (40-42) |
45 (44-46) |
50 (49-51) |
56 (55-57) |
64 (64-65) |
|
TB-BMD |
1.5 (1.4-1.6) |
1.5 (1.4-1.6) |
1.4 (1.3-1.5) |
1.3 (1.2-1.4) |
1.2 (1.1-1.3) |
1.0 (0.9-1.1) |
0.8 (0.7-0.9) |
0.5 (0.4-0.6) |
|
mJSW |
4.4 (4.1-4.7) |
3.9 (3.7-4.1) |
3.4 (3.3-3.5) |
2.6 (2.4-2.85) |
2.3 (2.2-2.4) |
1.7 (1.6-1.8) |
1.1 (1.0-1.2) |
0.4 (0.4-0.5) |
|
K/L-I’I’† |
THR-M73 (M72-M74) |
|
|||||||
PW-VAS |
43 (42-44) |
46 (45-48) |
50 (49-51) |
55 (54-56) |
61 (60-62) |
67 (66-68) |
74 (74-75) |
|
|
WOMAC-C |
33 (32-35) |
36 (35-38) |
40 (39-41) |
45 (44-46) |
51 (50-52) |
57 (56-58) |
63 (62-64) |
|
|
TB-BMD |
1.4 (1.3-1.5) |
1.3 (1.2-1.4) |
1.2 (1.1-1.3) |
1.1 (1.0-1.2) |
0.9 (0.8-1.0) |
0.7 (0.6-0.8) |
0.5 (0.4-0.6) |
|
|
mJSW |
4.3 (3.8-4.7) |
3.8 (3.7-4.0) |
3.3 (3.1-3.3) |
2.4 (2.3-2.65) |
2.0 (1.9-2.1) |
1.2 (1.1-1.3) |
0.5 (0.5-0.6) |
|
|
K/L-II’A’† |
THR-M61 (M60-M62) |
|
|||||||
PW-VAS |
45 (43-47) |
50 (49-52) |
55 (55-57) |
60 (58-62) |
65 (64-66) |
70 (69-71) |
|
|
|
WOMAC-C |
36 (35-37) |
40 (39-42) |
45 (45-47) |
50 (49-51) |
56 (55-57) |
62 (61-63) |
|
|
|
TB-BMD |
1.3 (1.2-1.4) |
1.1 (1.0-1.2) |
0.9 (0.8-1.0) |
0.7 (0.6-0.7) |
0.5 (0.4-0.6) |
0.3 (0.3-0.4) |
|
|
|
mJSW |
4.2 (3.7-4.7) |
3.6 (3.5-3.9) |
3.0 (2.9-3.1) |
2.2 (2.06-2.4) |
1.5 (1.4-1.6) |
0.5 (0.4-0.6) |
|
|
|
K/L-III’H’† |
THR-M61 (M60-M61) |
|
|||||||
PW-VAS |
48 (47-49) |
48 (47-50) |
52 (51-53) |
57 (58-61) |
63 (63-64) |
70 (69-70) |
|
|
|
WOMAC-C |
38 (37-39) |
38 (37-40) |
42 (41-43) |
48 (51-54) |
54 (53-55) |
62 (61-63) |
|
|
|
TB-BMD |
1.4 (1.3-1.5) |
1.3 (1.2-1.4) |
1.1 (1.0-1.2) |
0.9 (0.7-1.0) |
0.5 (0.4-0.6) |
0.3 (0.3-0.4) |
|
|
|
mJSW |
3.6 (3.2-4.0) |
3.1 (2.9-3.3) |
2.5 (2.4-2.6) |
1.6 (1.45-1.76) |
1.1 (1.0-1.2) |
0.4 (0.4-0.5) |
|
|
|
K/L-III’I’† |
THR-M49 (M48-M50) |
|
|||||||
PW-VAS |
50 (49-52) |
52 (51-54) |
56 (55-58) |
62 (60-63) |
70 (69-71) |
|
|
|
|
WOMAC-C |
41 (39-42) |
42 (41-44) |
45 (44-46) |
52 (51-53) |
62 (61-64) |
|
|
|
|
TB-BMD |
1.3 (1.2-1.4) |
1.1 (1.0-1.2) |
0.9 (0.8-1.0) |
0.7 (0.7-0.8) |
0.4 (0.4-0.5) |
|
|
|
|
mJSW |
3.5 (3.1-3.9) |
2.9 (2.7-3.2) |
2.1 (2.0-2.4) |
1.2 (1.1-1.45) |
0.4 (0.4-0.5) |
|
|
|
|
K/L-III’A’† |
THR-M37 (M36-M38) |
|
|||||||
PW-VAS |
52 (51-53) |
54 (53-57) |
60 (59-61) |
72 (71-73) |
|
|
|
|
|
WOMAC-C |
43 (43-45) |
45 (43-47) |
52 (50-54) |
64 (62-66) |
|
|
|
|
|
TB-BMD |
1.2 (1.1-1.3) |
0.9 (0.9-1.0) |
0.6 (0.6-0.7) |
0.3 (0.3-0.4) |
|
|
|
|
|
mJSW |
3.4 (3.0-3.8) |
2.6 (2.5-2.8) |
1.7 (1.7-1.9) |
0.4 (0.3-0.5) |
|
|
|
|
|
MMW-HA |
|
||||||||
K/L-II’H’† |
|
||||||||
PW-VAS |
41 (39-42) |
18 (17-19)# |
23 (22-24)# |
28 (27-29)# |
33 (32-35)* |
40 (39-41) |
50 (49-51) |
60 (61-63) |
75 (74-75) |
WOMAC-C |
31 (31-33) |
9 (8-10)# |
14 (13-15)# |
19 (18-20)# |
24 (23-26)* |
31 (30-32) |
40 (39-41) |
50 (51-53) |
65 (64-65) |
TB-BMD |
1.5 (1.4-1.6) |
1.5 (1.4-1.6) |
1.5 (1.4-1.6) |
1.4 (1.5-1.7) |
1.3 (1.6-1.8) |
1.2 (1.6-1.8) |
1.1 (1.4-1.6) |
1.0 (0.9-1.1) |
0.8 (0.7-0.9) |
mJSW |
4.4 (3.9-4.9) |
4.0 (3.9-4.1) |
3.6 (3.5-3.7) |
3.2 (3.1-3.3) |
2.8 (2.7-2.9) |
2.4 (2.3-2.5) |
2.0 (1.9-2.1) |
1.5 (1.4-1.6) |
1.0 (0.9-1.1) |
K/L-II’I’† |
|
THR-M97 (M96-M98) |
|||||||
PW-VAS |
43 (41-45) |
20 (19-210)# |
25 (24-26)# |
30 (29-31)# |
36 (35-37) |
44 (43-45) |
53 (52-54) |
63 (62-64) |
75 (74-75) |
WOMAC-C |
34 (32-36) |
10 (9-11)# |
16 (15-17)# |
20 (19-21)# |
26 (25-27) |
34 (33-35) |
43 (42-44) |
53 (52-54) |
65 (64-65) |
TB-BMD |
1.4 (1.3-1.5) |
1.4 (1.3-1.5) |
1.4 (1.4-1.6) |
1.3 (1.5-1.7) |
1.2 (1.6-1.8) |
1.1 (1.0-1.2) |
1.0 (0.9-1.1) |
0.8 (0.7-0.9) |
0.5 (0.4-0.5) |
mJSW |
4.3 (3.8-4.8) |
3.9 (3.8-4.0) |
3.4 (3.3-3.5) |
2.9 (2.7-3.1) |
2.4 (2.3-2.5) |
1.9 (1.8-2.0) |
1.4 (1.3-1.5) |
0.9 (0.8-1.0) |
0.4 (0.4-0.5) |
K/L-II’A’† |
THR-M78 (M78-M79) |
|
|||||||
PW-VAS |
45 (43-47) |
26 (25-27)# |
34 (33-35)# |
42 (41-43)* |
51 (50-52) |
61 (60-62) |
71 (70-72) |
|
|
WOMAC-C |
36 (34-37) |
15 (24-16)# |
25 (24-26)# |
33 (32-34)* |
42 (41-43) |
52 (51-53) |
63 (62-64) |
|
|
TB-BMD |
1.3 (1.1-1.3) |
1.2 (1.1-1.3) |
1.1 (1.0-1.2) |
1.0 (0.9-1.1) |
0.9 (0.8-1.0) |
0.7 (0.6-0.8) |
0.5 (0.4-0.6) |
|
|
mJSW |
4.2 (3.7-4.7) |
3.7 (3.7-4.0) |
3.2 (3.2-3.4) |
2.7 (2.6-2.8) |
2.1 (2.0-2.2) |
1.5 (1.4-1.6) |
0.8 (0.7-0.9) |
|
|
K/L-III’H’† |
THR-M73 (M72-M74) |
|
|||||||
PW-VAS |
48 (46-51) |
27 (26-27)# |
36 (35-37)# |
44 (43-45)* |
53 (52-54) |
63 (62-64) |
74 (73-75) |
|
|
WOMAC-C |
38 (36-40) |
18 (17-19)# |
27 (26-28)# |
35 (34-36)* |
44 (43-45) |
54 (53-55) |
64 (63-65) |
|
|
TB-BMD |
1.4 (1.3-1.5) |
1.4 (1.2-1.4) |
1.3 (1.2-1.4) |
1.2 (1.1-1.36) |
1.1 (1.0-1.1) |
0.9 (0.8-0.9) |
0.6 (0.5-0.6) |
|
|
mJSW |
3.6 (3.1-4.1) |
3.2 (3.0-3.4) |
2.7 (2.7-2.8) |
2.2 (2.1-2.3) |
1.6 (0.7-0.9) |
1.0 (1.0-1.1) |
0.4 (0.4-0.5) |
|
|
K/L-III’I’† |
THR-M61 (M60-M62) |
|
|||||||
PW-VAS |
50 (49-52) |
32 (31-33)# |
42 (41-43)* |
54 (53-55) |
65 (64-66) |
73 (72-74) |
|
|
|
WOMAC-C |
41 (39-43) |
23 (22-24)# |
33 (32-34)* |
45 (44-46) |
56 (55-57) |
63 (62-64) |
|
|
|
TB-BMD |
1.3 (1.2-1.4) |
1.4 (1.2-1.4) |
1.5 (1.3-1.5) |
1.6 (1.4-1.6) |
1.6 (1.4-1.6) |
0.5 (0.4-0.6) |
|
|
|
mJSW |
3.5 (3.0-4.0) |
2.9 (2.8-3.1) |
2.4 (2.3-2.5) |
1.8 (1.6-2.0) |
0.8 (0.7-0.9) |
0.5 (0.5-0.6) |
|
|
|
K/L-III ‘A’† |
THR-M49 (M48-M50) |
|
|||||||
PW-VAS |
53 (52-55) |
38 (37-39)# |
53 (52-54) |
63 (61-64) |
73 (72-74) |
|
|
|
|
WOMAC-C |
43 (41-45) |
29 (28-30)# |
44 (43-45) |
54 (53-55) |
64 (62-64) |
|
|
|
|
TB-BMD |
1.2 (1.1-1.3) |
1.1 (1.0-1.2) |
1.0 (0.9-1.1) |
0.8 (0.7-0.9) |
0.5 (0.4-0.5) |
|
|
|
|
mJSW |
3.4 (3.0-3.8) |
2.8 (2.7-2.9) |
2.1 (2.0-2.2) |
1.3 (1.2-1.5) |
0.5 (0.4-0.5) |
|
|
|
|
CS |
|
|
|
|
|
|
|
|
|
K/L-II’H’† |
|
|
|
|
|
|
|
THR-M85 (M84-M86) |
|
PW-VAS |
41 (40-42) |
19 (18-20) # |
27 (26-28)# |
35 (34-36)* |
44 (43-45) |
54 (53-55) |
64 (63-65) |
75 (74-75) |
|
WOMAC-C |
32 (31-33) |
9 (8-11) # |
17 (16-18)# |
25 (24-26)* |
34 (33-35) |
44 (43-45) |
54 (53-55) |
65 (64-65) |
|
TB-BMD |
1.5 (1.4-1.6) |
1.5 (1.4-1.6) |
1.4 (1.3-1.5) |
1.3 (1.2-1.4) |
1.2 (1.1-1.2) |
1.0 (0.9-1.1) |
0.8 (0.7-0.9) |
0.5 (0.4-0.6) |
|
mJSW |
4.4 (4.0-4.9) |
3.9 (3.7-4.1) |
3.4 (3.3-3.5) |
2.8(2.7-2.9) |
2.3 (2.2-2.4) |
1.8 (1.7-1.9) |
1.1 (1.0-1.2) |
0.4 (0.4-0.5) |
|
K/L-II-‘I’† |
|
|
|
|
|
|
THR-M73 (M72-M74) |
|
|
PW-VAS |
43 (41-45) |
25 (23-27)# |
34 (32-37)* |
43 (42-45) |
53 (52-54) |
63 (62-64) |
74 (73-75) |
|
|
WOMAC-C |
34 (32-36) |
15 (13-17)# |
25 (23-27)* |
34 (33-36) |
44 (43-45) |
54 (53-55) |
65 (64-65) |
|
|
TB-BMD |
1.4 (1.3-1.5) |
1.3 (1.2-1.4) |
1.2 (1.1-1.3) |
1.1 (1.0-1.2) |
1.0 (0.9-1.1) |
0.8 (0.7-0.9) |
0.5 (0.4-0.6) |
|
|
mJSW |
4.3 (3.8-4.8) |
3.8 (3.6-4.1) |
3.3 (3.2-3.4) |
2.5 (2.4-2.7) |
2.0 (2.1-2.2) |
1.2 (1.1-1.3) |
0.4 (0.4-0.5) |
|
|
K/L-III-‘H’† |
|
|
|
|
|
THR-M61 (M60-M62) |
|
|
|
PW-VAS |
48 (47-49) |
36 (35-37)# |
41 (40-42)* |
51 (50-52) |
62 (61-63) |
74 (73-75) |
|
|
|
WOMAC-C |
38 (37-39) |
26 (25-28)# |
31 (30-32)* |
41 (40-42) |
52 (51-53) |
64 (63-65) |
|
|
|
TB-BMD |
1.4 (1.3-1.5) |
1.3 (1.2-1.4) |
1.2 (1.1-1.3) |
1.0 (0.9-1.1) |
0.8 (0.7-0.9) |
0.5 (0.4-0.5) |
|
|
|
mJSW |
3.6 (3.1-4.1) |
3.1 (3.0-3.2) |
2.5 (2.4-2.6) |
1.8 (1.7-1.9) |
1.1 (1.0-1.2) |
0.4 (0.4-0.5) |
|
|
|
K/L-III-‘I’† |
|
|
|
|
THR-M49 (M48-M50) |
|
|
|
|
PW-VAS |
50 (48-52) |
40 (39-43)# |
51 (50-53) |
62 (61-63) |
74 (73-75) |
|
|
|
|
WOMAC-C |
41 (39-42) |
31 (29-33)# |
42 (51-54) |
53 (52-54) |
65 (64-65) |
|
|
|
|
TB-BMD |
1.3 (1.2-1.4) |
1.0 (0.9-1.1) |
0.8 (0.8-1.0) |
0.6 (0.6-0.8) |
0.4 (0.4-0.5) |
|
|
|
|
mJSW |
3.5 (3.0-4.0) |
2.9 (2.7-3.1) |
2.1 (2.1-2.3) |
1.3 (1.2-1.4) |
0.5 (0.4-0.6) |
|
|
|
|
PW - Pain at walking by VAS; WOMAC-C - WOMAC function scale; NS - control group; CS - IA-CS group; MMW-HA (Euflexxa group); †- Each study subgroup included 25 subjects; III/II -radiographic grade III /II -according to Kellgren-Lawrence; ‘A’; ‘I’; ‘H’ - atrophic, normotrophic, hypertrophic patterns; *- MCII responses. #- OARSI responses.
Changes in uctx-II levels over time for the different radiographic grades and patterns, under the different treatments are presented in Figure 10 and 10-a.