An Investigator-Initiated, Prospective, Single-Center, Open-Label Clinical Study to Evaluate Safety and Performance of Intra-Articular Hyaluronic Acid (IA-HA) (Biovisc Ortho) in Patients with Osteoarthritis (OA) of the Knee

Figures & data

Figure 1 Patient disposition.

Notes: 63 patients were screened for eligibility and were enrolled in the study after informed written consent. All patients were administered with IA-HA and were followed up. 3 patients were lost to follow-up and 60 patients completed the study.

Table 1 Summary of Patient Demographic Characteristics – Safety Population

Demographic Characteristic	Baseline (N=63)
Age (years)
Mean (SD)	54.22 (9.66)
Median (min, max)	55.00 (35.00, 74.00)
Sex, n (%)
Male	19.00 (30.16)
Female	44.00 (69.84)
Race/ethnicity, n (%)
Indian	63.00 (100.0)
Other	00 (00.00)
Height (cm)
Mean (SD)	158.8 (8.70)
Median (min, max)	160.0 (125.0, 187.0)
Weight (kg)
Mean (SD)	63.90 (10.40)
Median (min, max)	65.00 (40.00, 96.00)
BMI (kg/m^2)
Mean (SD)	25.09 (4.14)
Median (min, max)	24.80 (17.30, 38.50)

Notes: Percentages are based on the number of patients in the specified treatment.

Abbreviations: N, number of patients in the specified treatment; n, number of patients in a specified category.

Table 2 Symptoms of Knee Arthritis Present for Last 3 Months in All Enrolled Patients

Symptoms of Knee Arthritis	All Enrolled (N= 63)
	n	(%)
Pain	62	98.41
Swelling	29	46.03
Bony tenderness	27	42.85
Bony enlargement	1	1.58
Crepitus on active motion	55	87.30
Morning stiffness	23	36.50
No warmth of touch	1	1.58

Abbreviations: N, number of patients; n, number of patients in the specified category.

Figure 2 Summary of pain KOOS score.

Notes: Scores are mean±standard error. Primary efficacy end point –KOOS pain score was obtained at baseline, third injection cycle, fifth injection cycle, first follow-up visit and last follow-up visit. Gradual improvement in the KOOS pain score was observed at corresponding evaluable visits.

Table 3 Change from Baseline in KOOS Pain Score – PP Population

Visit		Statistics	PP (N=60)
Injection Cycle 1 (Screening/Baseline)		N	60
		Mean (SD)	42.93 (12.51)
		Median	44.5
		Min, max	0.00, 83.25
3rd Biovisc Ortho Injection Cycle (Visit 3)		N	60
		Mean (SD)	52.41 (8.66)
		Median	52.75
		Min, max	27.75, 72.25
	Change from Baseline to Visit 3	N	60
		Mean (SD)	9.48 (10.55)
		Median	11
		Min, max	−33.25, 44.50
		p-value	<0.0001
5th Biovisc Ortho Injection Cycle (Visit 5)		N	60
		Mean (SD)	59.55 (9.32)
		Median	61
		Min, max	39.00, 77.75
	Change from Baseline to Visit 5	N	60
		Mean (SD)	16.62 (12.25)
		Median	16.75
		Min, max	−16.50, 55.50
		p-value	<0.0001
	Change from Visit 3 to Visit 5	N	60
		Mean (SD)	7.14 (8.40)
		Median	5.75
		Min, max	−8.25, 25.00
		p-value	<0.0001
3 Months after last injection – FU 1 (Visit 6)		N	60
		Mean (SD)	67.06 (10.20)
		Median	69.5
		Min, max	39.00, 94.50
	Change from Baseline to Visit 6	N	60
		Mean (SD)	24.13 (15.48)
		Median	23.63
		Min, max	−33.25, 66.75
		p-value	<0.0001
	Change from Visit 6 to Visit 5	N	60
		Mean (SD)	7.51 (13.04)
		Median	5.5
		Min, max	−39.00, 30.75
		p-value	<0.0001
6 Months after last injection – FU 2 (Visit 7)		N	60
		Mean (SD)	72.65 (10.16)
		Median	72.25
		Min, max	50.00, 100.00
	Change from Baseline to Visit 7	N	60
		Mean (SD)	29.71 (15.74)
		Median	29.13
		Min, max	−16.50, 66.75
		p-value	<0.0001
	Change from Visit 7 to Visit 6	N	60
		Mean (SD)	5.59 (10.73)
		Median	5.5
		Min, max	−25.00, 30.75
		p-value	0.0002

Figure 3 Summary of KOOS score.

Notes: Summary of secondary efficacy analysis. (A) Summary of overall improvement in total KOOS, (B) summary of symptoms KOOS, (C) summary of function –activities of daily living (ADL) KOOS, (D) summary of function – sports and recreational activity KOOS, and (E) summary of quality of life (QoL) KOOS. Scores were obtained at baseline, third injection cycle, fifth injection cycle, first follow-up visit and last follow-up visit. Gradual improvement in the KOOS pain score was observed at corresponding evaluable visits. Scores are mean±standard error.