TY - JOUR
T1 - Hylan Versus Corticosteroid Versus Placebo for Treatment of Basal Joint Arthritis
T2 - A Prospective, Randomized, Double-Blinded Clinical Trial
AU - Heyworth, Benton E.
AU - Lee, Jonathan H.
AU - Kim, Paul D.
AU - Lipton, Carter B.
AU - Strauch, Robert J.
AU - Rosenwasser, Melvin P.
N1 - Funding Information:
This study was conducted at a single tertiary care center and was approved by the institutional review board. This investigator-sponsored study was funded with a joint grant from Genzyme Corporation and Wyeth Pharmaceuticals. U.S. Food and Drug Administration (FDA) approval for the study was obtained for use of hylan G-F 20 in an “off-label” use. Over a 2-year period, study patients were recruited and enrolled from the practices of the 2 senior authors and included patients older than 40 years of age with symptomatic basal joint osteoarthritis (BJOA). The condition was diagnosed using standard radiographic and clinical criteria: basal joint tenderness, thumb or wrist pain at rest or with activity, joint stiffness, decreased mobility, deformity, instability, and decreased manual function. Because radiographic grade does not necessarily correlate with the symptoms of patients with basal joint arthritis, 1,22 patients were not excluded based on radiographic grade. Patients who had received previous corticosteroid injections were excluded if they had not experienced at least mild to moderate pain relief or functional improvement from the injections, if they had received more than 2 such injections in the affected joint in the past, or if they had received such an injection in the preceding 6 months. Those patients who received 1 or 2 prior injections with at least moderate improvement were included, because they would likely have another good response to a second or third injection. Other exclusion criteria included pregnancy, prior surgery on the affected thumb or wrist, history of infection in the affected joint, history of inflammatory arthritis, and skin disease or eruption at the joint injection site. Patients with a known allergy to eggs, feathers, avian proteins, or HA derivative products were also excluded, as hylan G-F is derived from rooster combs.
Funding Information:
Supported by a grant from Wyeth-Ayerst Pharmaceuticals and Genzyme Corporation.
PY - 2008/1
Y1 - 2008/1
N2 - Purpose: Conservative, nonsurgical therapies for basal joint osteoarthritis, such as thumb spica splinting and intra-articular corticosteroid injections, remain the mainstays for symptomatic treatment. This study compares intra-articular hylan, corticosteroid, and placebo injections with regard to pain relief, strength, symptom improvement, and metrics of manual function in a randomized, controlled, double-blinded study. Methods: Sixty patients with basal joint arthritis were randomized to receive 2 intra-articular hylan injections 1 week apart, 1 placebo injection followed by 1 corticosteroid injection 1 week later, or 2 placebo injections 1 week apart. Patients were evaluated at 2, 4, 12, and 26 weeks and assessed with Visual Analog Scale pain scores, strength measures, difference scores, Disabilities of the Arm, Shoulder, and Hand (DASH) scores, and range of motion measurements. Results: All groups reported pain relief at 2 weeks. The steroid and placebo groups had significantly less pain at week 4 compared with baseline, but this effect disappeared by week 12. Only hylan injections continued to provide pain relief at 12 and 26 weeks compared with baseline. There were no significant differences in pain between groups at any time. At 12 and 26 weeks, the hylan group had improved grip strength compared with baseline, whereas the steroid and placebo groups were weaker. At 4 weeks, the steroid group reported in the difference score a greater improvement in symptoms (68%) compared with the hylan (44%) and placebo (50%) groups. Whereas at 26 weeks the hylan group reported the largest improvement in symptoms (68%), this was not statistically different from the placebo (47%) and steroid (58%) groups. There were no significant differences in Disabilities of the Arm, Shoulder, and Hand scores or range of motion among the groups. There were no complications from any injection. Conclusions: There were no statistically significant differences among hylan, steroid, and placebo injections for most of the outcome measures at any of the follow-up time points. However, based on the durable relief of pain, improved grip strength, and the long-term improvement in symptoms compared with preinjection values, hylan injections should be considered in the management of basal joint arthritis of the thumb. Type of study/level of evidence: Therapeutic I.
AB - Purpose: Conservative, nonsurgical therapies for basal joint osteoarthritis, such as thumb spica splinting and intra-articular corticosteroid injections, remain the mainstays for symptomatic treatment. This study compares intra-articular hylan, corticosteroid, and placebo injections with regard to pain relief, strength, symptom improvement, and metrics of manual function in a randomized, controlled, double-blinded study. Methods: Sixty patients with basal joint arthritis were randomized to receive 2 intra-articular hylan injections 1 week apart, 1 placebo injection followed by 1 corticosteroid injection 1 week later, or 2 placebo injections 1 week apart. Patients were evaluated at 2, 4, 12, and 26 weeks and assessed with Visual Analog Scale pain scores, strength measures, difference scores, Disabilities of the Arm, Shoulder, and Hand (DASH) scores, and range of motion measurements. Results: All groups reported pain relief at 2 weeks. The steroid and placebo groups had significantly less pain at week 4 compared with baseline, but this effect disappeared by week 12. Only hylan injections continued to provide pain relief at 12 and 26 weeks compared with baseline. There were no significant differences in pain between groups at any time. At 12 and 26 weeks, the hylan group had improved grip strength compared with baseline, whereas the steroid and placebo groups were weaker. At 4 weeks, the steroid group reported in the difference score a greater improvement in symptoms (68%) compared with the hylan (44%) and placebo (50%) groups. Whereas at 26 weeks the hylan group reported the largest improvement in symptoms (68%), this was not statistically different from the placebo (47%) and steroid (58%) groups. There were no significant differences in Disabilities of the Arm, Shoulder, and Hand scores or range of motion among the groups. There were no complications from any injection. Conclusions: There were no statistically significant differences among hylan, steroid, and placebo injections for most of the outcome measures at any of the follow-up time points. However, based on the durable relief of pain, improved grip strength, and the long-term improvement in symptoms compared with preinjection values, hylan injections should be considered in the management of basal joint arthritis of the thumb. Type of study/level of evidence: Therapeutic I.
KW - Basal joint arthritis
KW - corticosteroid
KW - hylan
KW - osteoarthritis
KW - viscosupplementation
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U2 - 10.1016/j.jhsa.2007.10.009
DO - 10.1016/j.jhsa.2007.10.009
M3 - Article
C2 - 18261664
AN - SCOPUS:38749138906
SN - 0363-5023
VL - 33
SP - 40
EP - 48
JO - Journal of Hand Surgery
JF - Journal of Hand Surgery
IS - 1
ER -