Navigating the New EU Medical Devices Regulation: Retrospective Post-Market Follow-Up of Hyaluronic Acid Injections for Knee Osteoarthritis

Figures & data

Table 1 Sociodemographic and Clinical Variables.

Variable	Value [n (%)]
Sex	Female 16 (80%)
Employment status	Non-active 11 (55%)
Comorbidities	Present 18 (90%)
Pathologies*	Hypertension 12 (60%)
	Diabetes Mellitus 4 (20%)
	Obesity 7 (35%)
	Cancer 3 (15%)
	Other 16 (80%)
Laterality (R/L/B)	9 (45%) / 8 (40%) / 3 (15%)
Kellgren (I/II/III/IV)	4 (20%) / 4 (20%) / 7 (35%) / 5 (25%)

Notes: *Referred to number of patients. Multiple options possible. Abbreviations: R= right; L = left; B = bilateral.

Table 2 Pharmacological Treatments

OA-related treatments*	NSAIDs 6 (30%)
	Paracetamol 13 (65%)
	Other analgesics 10 (50%)
	SYSADOAs 1 (5%)
	Opioids 8 (40%)
Non-OA-related treatments*	Oral antidiabetics 4 (20%)
	Antihypertensive 12 (60%)
	Hypocholesterolemic agents 5 (25%)
	Psychotropic drugs 6 (30%)
	Other 15 (75%)

Notes: *Referred to number of patients. Multiple options possible.

Table 3 Bivariate Comparative Analysis Results

Variable	Improvement	Non Improvement	P
	(N = 13)	(N = 7)
Age, mean (SD)	61.0 (14.9)	61.1 (29.5)	0.634
Women, n (%)	11 (84.6)	5 (71.4)	0.439
Non-active, n (%)	7 (53.8)	4 (57.1)	0.630
Kellgren-Lawrence III + IV, n (%)	8 (61.5)	4 (57.1)	0.608
Comorbidities, n (%)	11 (84.6)	7 (100)	0.411
Days until appointment request, mean (SD)	316 (160)	160 (70)	0.032
Previously IA AH injected, n (%)	7 (53.8)	5 (71.4)	0.392
Previous IA AH injections number, mean (SD)	0.69 (0.85)	0.86 (0.69)	0.455
Concomitant treatments for OA, mean (SD)	2.15 (0.69)	1.43 (0.53)	0.031

Abbreviations: OA, osteoarthritis; HA, hyaluronic acid; IA, intra-articular; LMP, lateral midpatellar; NSAIDs, non-steroidal anti-inflammatory drugs; SD, standard deviation; R/L/B, right/left/bilateral.