Background/Purpose:   Painful carpometacarpal osteoarthritis (CMC OA) is associated with substantial impairment, and is often unresponsive to medical treatment.    Hylan G-F 20 has been shown to improve pain and function in patients with knee OA; however, its effectiveness in CMC OA is unknown. 

Methods: 200 patients with radiologic evidence of CMC OA and no inflammatory arthritis were randomized to receive one of the following three regimens: 1cc of Hylan G-F 20 weekly for 2 weeks; 1cc triamcinolone acetonide (40mg) followed 1 week later by 1cc 0.5% bupivacaine; or 0.5% 1cc bupivacaine weekly for 2 weeks.  Randomization was double blind and stratified on previous intra-articular steroid treatment.  An experienced hand surgeon performed all injections without radiologic guidance. Patients were assessed 26 weeks after the first injection. An intention to treat, last–value carried forward analysis was performed on all patients who had at least one post-injection visit.

Results:   188 patients were eligible for this analysis.  Average age was 66.5 years (range 45-89), 67.7% female and 90.4% Caucasian.  33%, 31% and 38 % had previously received a corticosteroid injection in the Hylan G-F 20, triamcinolone and bupivacaine groups respectively. 100 (53%) had Kellegren and Lawrence (K+L) Grade <=3 in the CMC joint and 88 (47%) had K+L Grade 4.  At 26 weeks, pain as measured by the Visual Analogue Scale (VAS) showed statistically and clinically significant improvement in all treatment groups.  However, there was no statistically or clinically significant difference in VAS between treatment arms at 26 weeks.   No treatment arm resulted in clinically meaningful improvements in function, as measured by the Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH).  In a multivariate regression analysis, controlling for age, sex, K+L grade, baseline pain and treatment assignment, neither K+L Grade nor treatment assignment was associated with a difference in pain at 26 weeks.  Among those with severe K+L Grade 4 CMC OA, all three treatments led to clinically and statistically significant improvements in pain at 26 weeks, with no differences between groups.

Conclusion: In patients with CMC OA, intra-articular Hylan G-F 20 was not superior to corticosteroids or bupivacaine in reducing pain and improving function at 26 weeks.  All three treatments resulted in significant improvements in pain, even among patients with severe CMC OA.  A variety of injectable therapies appear to be effective treatments for this condition, even in those with severe arthritis.

TABLE 1.	Hylan G-F 20 Mean ± s.d.	Triamcinolone Mean ± s.d.	Bupivacaine Mean ± s.d
All Patients (188)
VAS Baseline(100=severe)	60.7±19.3	63.2±20.2	57.1±20.1
VAS 26 weeks	49.8±26.3	50.1±29.4	42.9±26.5
Delta VAS	-10.9±26.7	-13.1±29.9	-14.2±20.8
p-value within group change	0.002	0.003	<0.0001
DASH Baseline	28.8±17.3	28.9±17.9	25.7±17.1
DASH 26 Weeks	26.1±19.0	27.0±18.0	24.2±17.4
Delta DASH(N=175*)	-3.53±11.4	-2.88±14.9	-1.39±12.3
p-value within group change	0.02	0.14	0.07
K+L <3 (N=100)
VAS for Pain	61.7±19.5	64.8 ±18.8	51.1±23.4
VAS at 26 weeks	51.6±28.8	56.8±31.6	40.6±28.9
Delta VAS	-10.1±23.7	-7.96 ±29.1	-10.5±21.3
p-value within group change	0.02	0.22	0.02
K+L 4 (N=88)
VAS for Pain	59.3±19.3	61.1±22.1	61.9±16.0
VAS at 26 weeks	47.3±22.6	41.3±23.9	44.8±24.8
Delta VAS	-12.0±30.9	-19.8±30.0	-17.1±20.2
P-value within group change	0.009	0.003	<0.0001
* N=175 due to missing data

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-randomized-controlled-trial-of-hylan-g-f-20-for-the-treatment-of-carpometacarpal-osteoarthritis/