Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2011 Oct;2(4):384-8.
doi: 10.1177/1947603511400184.

Intra-articular Duration of Durolane™ after Single Injection into the Rabbit Knee

Katarina Edsman  1 , Roland Hjelm  1 , Helena Lärkner  1 , Lars I Nord  1 , Anders Karlsson  1 , Åsa Wiebensjö  1 , A Urban Höglund  2 , Anne Helander Kenne  1 , Jacques Näsström  3
Affiliations

Intra-articular Duration of Durolane™ after Single Injection into the Rabbit Knee

Katarina Edsman et al. Cartilage. 2011 Oct.

Abstract

Objective: The aim of the present study was to investigate the intra-articular duration of Durolane™ in a rabbit model to allow comparison between Durolane™ residence time and data reported for other hyaluronic acid products as well as native hyaluronic acid.

Design: (14)C-labeled Durolane™ was manufactured by labeling the cross-linker used for stabilization. A single injection of approximately 0.3 mL (14)C-labeled Durolane™ was administered intra-articularly in both knee joints of male New Zealand White rabbits. At days 1, 2, 3, 7, 28, 60, 96, and 120 after injection, the knee joints of 4 animals were collected, and the radioactivity of the remaining gel was measured. The obtained data were fitted by exponential models to calculate the half-life of the gel. Two additional rabbits were used for histology of the joint 127 days after the injection.

Results: The elimination of (14)C-labeled Durolane™ followed first-order kinetics with an apparent half-life of approximately 32 days. Histology showed no morphological changes in the knee joints.

Conclusions: This study shows that Durolane™ has a half-life of 32 days in the rabbit knee joint, which is much longer compared to literature data on hyaluronic acid and other modified hyaluronic acid products.

Keywords: Durolane™; duration; hyaluronic acid; intra-articular; osteoarthritis.

PubMed Disclaimer

Conflict of interest statement

Declaration of Conflicting Interests: At the time of the study, authors K.E., R.H., H.L., L.I.N., A.K., Å.W., A.H.K., and J.N. were all employed by Q-Med AB Sweden.

Figures

Figure 1.
Figure 1.
Percentage of remaining gel, obtained from the remaining activity of the gel injected, plotted on a log scale against time. The elimination was found to follow first-order kinetics with a half-life of approximately 32 days (95% confidence interval, 24-46 days; R2 = 0.70). Two observations were outliers (outside 2 standard deviations from average) and were not included in the graph or the calculations.
Figure 2.
Figure 2.
Histology section of the rabbit knee joint stained with hematoxylin/eosin, 127 days after a single injection of 14C-labeled Durolane™. No morphological changes were observed in the synovial membrane (sm) or the articular part of the tibia (t).
See this image and copyright information in PMC

References

    1. Balazs EA, Denlinger JL. Viscosupplementation: a new concept in the treatment of osteoarthritis. J Rheumatol. 1993;39(Suppl): 3-9. - PubMed
    1. Balazs EA, Watson D, Duff IF, Roseman S. Hyaluronic acid in synovial fluid: I. Molecular parameters of hyaluronic acid in normal and arthritis human fluids. Arthritis Rheum. 1967;10:357-76. - PubMed
    1. Mazzucco D, Scott R, Spector M. Composition of joint fluid in patients undergoing total knee replacement and revision arthroplasty: correlation with flow properties. Biomaterials. 2004;25:4433-45. - PubMed
    1. Fam H, Bryant JT, Kontopoulou M. Rheological properties of synovial fluids. Biorheology. 2007;44:59-74. - PubMed
    1. Ghosh P, Guidolin D. Potential mechanism of action of intra-articular hyaluronan therapy in osteoarthritis: are the effects molecular weight dependent? Semin Arthritis Rheum. 2002;32:10-37. - PubMed

LinkOut - more resources