Randomized prospective study evaluating addition of corticoid to viscosupplementation: three months of follow-up

Campos, Gustavo Constantino de; Rezende, Márcia Uchôa de; Pailo, Alexandre Felício; Frucchi, Renato; Pasqualim, Thiago; Camargo, Olavo Pires de

doi:10.1016/j.rbo.2012.08.006

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Original Article • Rev. bras. ortop. 48 (4) • Aug 2013 • https://doi.org/10.1016/j.rbo.2012.08.006 copy

Randomized prospective study evaluating addition of corticoid to viscosupplementation: three months of follow-up^⋆ ⋆ Work performed in the Medical Investigation Laboratory for the Musculoskeletal System (LIM41), Department of Orthopedics and Traumatology, Hospital das Clínicas, School of Medicine, Universidade de São Paulo, São Paulo, SP, Brazil

Authorship SCIMAGO INSTITUTIONS RANKINGS

OBJECTIVE:

To assess if the initial results of viscosupplementation are improved by the addition of corticosteroid.

DESIGN:

We evaluated 104 patients receiving usual care for knee osteoarthritis at the Universidade de São Paulo Medical Center. Patients were randomized to receive either a single intra-articular injection of 6 mL of Hylan GF-20 (Group 1) or a single intra-articular injection of 6 mL of Hylan GF-20 plus 1 mL (20 mg) of Triamcinolone Hexacetonide (Group 2). VAS, WOMAC and Lequesne questionnaires were applied at weeks zero (prior the injection), and after one, four, and 12 weeks.

RESULTS:

The baseline measurements of the two groups with 52 patients each were not statistically different. At week one, WOMAC and VAS showed significantly better results for Group 2 compared to Group 1 (p < 0,05). At week four the scores did not show a statistically significant differences. The groups showed similar results at week 12.

CONCLUSION:

The addition of Triamcinolone Hexacetonide improves the short term symptom/functional scores of viscosupplementation.

Adrenal cortex hormones; Clinical trial; Controlled clinical trial; Double-blind method; Hyaluronic acid Injections, intra-articular; Osteoarthritis, knee; Pain measurement; Treatment outcome; Viscosupplementation

Variable	Group 1		Group 2		Total		p
	n	%	n	%	n	%
Gender							0.819
Male	13	25	12	23.1	25	24
Female	39	75	40	76.9	79	76
Ethnicity							0.823#
Oriental	1	1.9	1	1.9	2	1.9
White	33	63.5	36	69.2	69	66.3
Black	4	7.7	5	9.6	9	8.7
Mixed	14	26.9	10	19.2	24	23.1
Kellgreen & Lawrence							0.969
1	7	13.5	6	11.5	13	12.5
2	14	26.9	16	30.8	30	28.8
3	18	34.6	18	34.6	36	34.6
4	13	25	12	23.1	25	24

Variable	Group	Mean	SD	IC (95%)		n	p
				MIN	MAX
Age	1	60.75	11.71	57.49	64.01	52	0.062
Age	2	64.65	9.14	62.11	67.2	52
Weight	1	79.63	14.6	75.57	83.7	52	0.136
Weight	2	75.77	11.47	72.58	78.96	52
Height	1	1.63	0.09	1.6	1.65	52	0.773
Height	2	1.62	0.08	1.6	1.64	52
BMI	1	30.18	5.24	28.72	31.64	52	0.157
BMI	2	28.87	4.08	27.73	30	52

Variable	Time	Time	SD	IC (95%)		n	Mean	SD	IC (95%)		n
				inf	sup				inf	sup
WOMAC	Baseline	50.21	16.15	45.71	54.71	52	54.54	17.58	49.65	59.43	52
	Week 1	45.83	18.52	40.67	50.98	52	34.38	20.04	28.81	39.96	52
	Week 4	39	1.87	33.97	44.03	51	31.75	17.58	26.86	36.64	52
	Week 12	34.48	19.25	28.76	40.19	46	36.43	16.5	31.58	41.27	47
	Week 24	36.72	19.05	31.06	42.37	46	38.11	16.72	33.2	43.01	47
WOMAC Pain	Baseline	9.94	3.64	8.93	10.96	52	10.85	3.68	9.82	11.87	52
	Pain	8.87	4.54	7.6	10.13	52	7.04	4.37	5.82	8.25	52
	Week 4	7.68	3.95	6.52	8.84	51	6.92	4.28	5.74	8.1	52
	Week 12	6.74	3.7	5.64	7.84	46	7.02	3.6	5.97	8.08	47
	Week 24	7.33	3.72	6.22	8.43	46	7.47	3.37	6.48	8.46	47
VAS	Baseline	67.27	20.08	61.68	72.86	52	70.21	23.59	63.64	76.78	52
	Week 1	55.29	26.52	47.91	62.67	52	38.52	24.65	31.66	45.38	52
	Week 4	50.41	24.1	43.63	57.19	51	37.4	25.24	30.38	44.43	52
	Week 12	46.22	26.18	38.44	53.99	46	46.7	23.51	39.71	53.68	47
	Week 24	49.41	21.94	42.74	56.08	46	50.15	23.46	43.26	57.04	47
Lequesne	Baseline	13.24	3.85	12.17	14.31	52	13.86	4.18	12.69	15.02	52
	Week 1	11.86	4.05	10.74	12.99	52	10.93	4.73	9.61	12.25	52
	Week 4	10.96	4.13	9.8	12.12	51	9.7	4.12	8.55	10.85	52
	Week 12	9.73	4.05	8.52	10.93	46	10.87	3.79	9.74	12	47
	Week 24	10.32	4.27	9.02	11.62	46	11.45	3.7	10.36	12.53	47

Adverse effects		Group 1		Group 2		Total		p
		n	%	n	%	n	%
Pain	-	44	86.5	41	78.8	86	82.7	0.3
Pain	+	8	13.5	11	21.2	18	17.3
Effusion	-	49	94.2	50	96.2	99	95.2
Effusion		3	5.8	2	3.8	5	4.8	> 0,999*

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[1] *Corresponding author at: Rua Louis Pasteur, 75, casa 25, Parque Alto Taquaral Campinas, SP, Brazil CEP: 13087-773 E-mail: gustavoccampos@terra.com.br (G.C. Campos).