Mid-term outcomes of microfragmented adipose tissue plus arthroscopic surgery for knee osteoarthritis: A randomized, active-control, multicenter clinical trial

Table 1 Baseline characteristics of the patients

Characteristics	MFAT group	Control group	P value
No. of knees	146	146
Age, yr	56.4 ± 10.6	54.8 ± 10.1	0.183
Sex, n (%)			0.455
Female	95 (65.1)	101 (69.2)
Male	51 (34.9)	45 (30.8)
BMI, kg/m2	22.6 ± 3.4	23.1 ± 3.1	0.246
Kellgren-Lawrence grade, n (%)			0.833
2	80 (54.8)	93 (63.7)
3	66 (45.2)	53 (36.3)
Osteoarthritis site, n (%)			0.815
Left	70 (47.9)	72 (49.3)
Right	76 (52.1)	74 (50.7)
VAS pain	5.3 ± 1.4	5.2 ± 1.3	0.637
WOMAC score
Pain 0-20	9.8 ± 2.7	9.5 ± 2.6	0.264
Stiffness 0-8	2.3 ± 1.4	2.2 ± 1.3	0.519
Function 0-68	35.3 ± 8.4	33.6 ± 10.2	0.115
Total 0-96	47.5 ± 9.6	45.3 ± 11.0	0.071
Lequesne index	10.7 ± 2.8	10.3 ± 2.6	0.215
WORMS	59.1 ± 9.2	60.8 ± 7.0	0.648

WORMS: Whole-Organ Magnetic Resonance Imaging Score; VAS: Visual analog scale; BMI: Body mass index; MFAT: Microfragmented adipose tissue.

Table 2 Primary and second outcomes of the trial from baseline to all follow-ups

	MFAT group (n = 146)	Control group (n = 146)	F value	P value
WOMAC total score
Baseline	48.3 ± 12.9	46.5 ± 13.4	0.4061	0.2331
6 mo	23.5 ± 8.6	29.8 ± 10.9	20.0021	< 0.0011
12 mo	22.0 ± 8.1	29.8 ± 10.7	24.4791	< 0.0011
24 mo	22.8 ± 8.2	31.7 ± 12.6	26.7631	< 0.0011
F value	379.381	141.9161	23.468
P value	< 0.0011	< 0.0011	< 0.0012
WOMAC pain score
Baseline	9.8 ± 2.7	9.5 ± 2.6	1.5441	0.2641
6 mo	4.3 ± 2.0	5.7 ± 2.7	18.3731	< 0.0011
12 mo	4.0 ± 2.0	5.7 ± 2.2	32.0461	< 0.0011
24 mo	4.0 ± 2.0	5.9 ± 2.3	45.1151	< 0.0011
F value	676.7411	240.461	36.69
P value	< 0.0011	< 0.0011	< 0.0012
WOMAC stiffness score
Baseline	3.2 ± 1.7	3.3 ± 2.0	0.0031	0.9241
6 mo	2.0 ± 1.4	2.4 ± 1.6	9.5051	0.0541
12 mo	1.7 ± 1.3	2.3 ± 1.4	13.7371	< 0.0011
24 mo	1.6 ± 1.2	2.2 ± 1.4	13.5481	< 0.0011
F value	155.1171	29.1401	9.605
P value	< 0.0011	< 0.0011	< 0.0012
WOMAC function score
Baseline	35.3 ± 12.3	33.8 ± 12.8	0.4061	0.3041
6 mo	17.1 ± 8.3	21.7 ± 10.2	20.0021	< 0.0011
12 mo	16.3 ± 7.6	21.9 ± 10.2	24.4791	< 0.0011
24 mo	17.2 ± 7.8	23.6 ± 11.8	26.7631	< 0.0011
F value	379.381	141.9151	23.468
P value	< 0.0011	< 0.0011	< 0.0012
VAS pain
Baseline	5.3 ± 1.4	5.2 ± 1.3	0.2571	0.6071
6 mo	2.9 ± 1.3	3.3 ± 1.6	5.3551	0.0081
12 mo	2.2 ± 1.3	2.7 ± 1.5	5.9371	0.0071
24 mo	2.2 ± 1.4	2.7 ± 1.6	7.8351	0.0061
F value	581.2061	527.7971	11.921
P value	< 0.0011	< 0.0011	< 0.0012
Lequesne index
Baseline	10.7 ± 2.8	10.3 ± 2.7	2.3271	0.2171
6 mo	7.7 ± 3.2	8.0 ± 3.0	01	0.4581
12 mo	7.2 ± 3.2	8.2 ± 3.3	6.6841	0.0121
24 mo	7.2 ± 2.5	8.2 ± 3.0	8.6331	0.0041
F value	216.5541	45.1361	16.293
P value	< 0.0011	< 0.0011	< 0.0012

¹F statistic and P value of the main effect.

²F statistic and P value of the crossover effect.

WORMS: Whole-Organ Magnetic Resonance Imaging Score; VAS: Visual analog scale; MFAT: Microfragmented adipose tissue.

Table 3 Comparison of the Whole-Organ Magnetic Resonance Imaging Score before and after treatment in the microfragmented adipose tissue and the control group

	MFAT group	Control group	t value	P value
Baseline	58.9 ± 15.9	60.8 ± 19.0	0.243	0.811
24 mo	55.0 ± 15.5	62.1 ± 18.7	0.924	0.367
t value	2.814	-0.195
P value	0.0203	0.85

WORMS: Whole-Organ Magnetic Resonance Imaging Score; MFAT: Microfragmented adipose tissue.