Injectable hyaluronan for the treatment of carpometacarpal osteoarthritis: open label pilot trial

ABSTRACT

Objective: Carpometacarpal osteoarthritis (CMC OA) is highly prevalent in older adults, and is often unresponsive to medical treatment. Intra-articular Hylan G-F 20 has been shown to improve pain and function in patients with knee OA; however, its effectiveness in CMC OA is less clear.

Methods: 32 patients with CMC OA were injected with Hylan G-F 20, once weekly for three consecutive weeks. Patients were assessed 4, 12, 20 and 26 weeks after the first injection. A last-value carried forward analysis was performed.

Results: Average age was 64 years, (range 46–79), 69% were female and 97% Caucasian. Fifty-three percent had at least one previous corticosteroid injection in the affected CMC joint. At 26 weeks, mean visual analogue scale (VAS) for pain had improved significantly (15.2 mm; p-value = 0.006). Disabilities of the arm, shoulder and hand questionnaire (DASH) scores also improved significantly (12.6; p-value < 0.001). A DASH change of 10–14 is considered clinically meaningful. Neither key strength nor opposition grip strength improved. VAS scores for pain at 26 weeks showed good correlation with patient satisfaction (Spearman r = 0.52, p-value < 0.01). Adverse events potentially related to the injections included three episodes of post-injection pain and swelling, and one case of crystal proven pseudogout.

Conclusion: Intra-articular Hylan G-F 20 injections reduced pain and improved function in patients with CMC OA at 26 weeks in this small open label study. Limitations of this study include its small, open label design. Larger randomized controlled trials are needed to confirm these results, and to determine predictors of response to treatment.

Clinical trial registration: This study was approved by the Institutional Review Board at the Hospital for Special Surgery, New York, NY, USA and registered at www.clinicatrials.gov # NCT00198029.

Key words: :

• Carpometacarpal joint
• Hyaluronan
• Osteoarthritis

Transparency

Declaration of funding

This study was supported in part by grants from Wyeth Pharmaceuticals and Genzyme Biosurgery.

Declaration of financial/other relationships

L.A.M. has disclosed that she is supported by NIH K23 AR050607 and by an Arthritis Investigator Award from the Arthritis Foundation. J.N.K. has disclosed that he is supported by NIH P60 AR 47782 and NIH K24 02123. S.L. has disclosed that he is supported by NIAMS R03 AR 05063. The other authors have disclosed no competing interests. None of the funding agencies had any role in research design, data analysis or assistance in manuscript preparation.

All peer reviewers receive honoraria from CMRO for their review work. Peer reviewer 1 has disclosed that he/she acts in an advisory role for, and holds stock in, Labopharm Canada. The other reviewer has disclosed that he/she has no relevant financial relationships.

Acknowledgment

The authors disclose no outside editorial assistance in preparing this paper.