A phase I–II controlled randomized trial using a promising novel cell-free formulation for articular cartilage regeneration as treatment of severe osteoarthritis of the knee

Table 1 Distribution of the main clinical characteristics of the subjects at the beginning of the study

Clinical characteristic	Arthroplasty	NSAIDs	BIOF2	P
Men (%)	50.0%	62.5%	50.0%	0.84*
Age (years)	62.8 ± 8.6	68.0 ± 7.1	68.5 ± 8.9	0.34**
BMI	29.5 ± 2.9	29.8 ± 2.1	28.0 ± 3.3	0.41**
Smoking	37.5%	25.0%	25.0%	0.81*
Diabetes	37.5%	25.0%	12.5%	0.51*
High blood pressure	62.5%	37.5%	50%	0.60*
WOMAC	73.3 ± 15.2	61.6 ± 16.0	62.7 ± 21.6	0.366**
Rasmussen	15.0 ± 7.0	14.0 ± 2.2	12.7 ± 3.6	0.643**
RAPID3	7.0 ± 1.5	8.3 ± 0.6	7.4 ± 1.1	0.103**

Percentages or averages and standard deviation are shown. BMI body mass index.* Fisher’s exact test; **One-way ANOVA

ISSN: 2047-783X