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Penetration of topical diclofenac sodium 4 % spray gel into the synovial tissue and synovial fluid of the knee: a randomised clinical trial

  • Knee
  • Published:
Knee Surgery, Sports Traumatology, Arthroscopy Aims and scope

Abstract

Purpose

The present study was designed to evaluate the penetration of diclofenac sodium 4 % spray gel in synovial tissue, synovial fluid and blood plasma after topical application in subjects with joint effusions and planned total knee arthroplasty (TKA) due to osteoarthritis.

Methods

A total of 39 patients were randomised to two- or three-times daily application of diclofenac sodium 4 % spray gel to knees requiring surgery over a treatment period of 3 days. Within 8 h after the last application, TKA was conducted, and the diclofenac concentrations in synovial tissue, synovial fluid and blood plasma were measured by liquid chromatography.

Results

The median diclofenac concentration was approximately 10–20-fold higher in synovial tissue (36.2 and 42.8 ng/g) than in synovial fluid (2.6 and 2.8 ng/mL) or plasma (3.9 and 4.1 ng/mL) in both treatment groups. Dose proportionality for any compartment or treatment groups could not be detected. Treatment-related adverse events were noted in two cases and limited to skin reactions.

Conclusion

Diclofenac sodium 4 % spray gel was found to penetrate the skin locally in substantial amounts and thus reach the desired target tissue. Concentrations were not dose-dependent, and application was well tolerated by 97.4 % of patients. Topical application of diclofenac should be considered a valuable alternative to systemic NSAID therapy in the initial treatment of osteoarthritis.

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Acknowledgments

The authors thank Kate McFarlane for her support in preparing the manuscript and proofreading.

Conflict of interest

T.E. and M.D.S. are consultants to Smith and Nephew, Endoscopy. The study was supported by MIKA Pharma.

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Authors and Affiliations

  1. Department of Orthopaedics and Rheumatology, University Hospital Marburg, Baldingerstrasse, 35043, Marburg, Germany

    Turgay Efe, Ercan Sagnak, Philip P. Roessler, Thilo Patzer, Susanne Fuchs-Winkelmann, Christian D. Peterlein & Markus D. Schofer

  2. Department of Orthopaedics and Trauma, University Hospital Schleswig–Holstein, Campus, Lübeck, Germany

    Ercan Sagnak

  3. University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK

    Alan Getgood

  4. Department of Orthopaedics, University Hospital Düsseldorf, Düsseldorf, Germany

    Thilo Patzer

  5. ORTHOmedic Gelenkzentrum Frankfurt-Offenbach, Offenbach, Germany

    Markus D. Schofer

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  1. Turgay Efe
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Correspondence to Turgay Efe.

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Efe, T., Sagnak, E., Roessler, P.P. et al. Penetration of topical diclofenac sodium 4 % spray gel into the synovial tissue and synovial fluid of the knee: a randomised clinical trial. Knee Surg Sports Traumatol Arthrosc 22, 345–350 (2014). https://doi.org/10.1007/s00167-013-2408-0

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  • DOI: https://doi.org/10.1007/s00167-013-2408-0

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