PM&R
Volume 2, Issue 4 , Pages 259-267 , April 2010

Efficacy and Safety of Hylan G-F 20 for Symptomatic Glenohumeral Osteoarthritis: A Prospective, Pilot Study

  • Victoria Anne Brander, MD

      Affiliations

    • Physical Medicine and Rehabilitation, Northwestern University Feinberg School of Medicine, Northwestern Orthopedic Institute, 680 North Lake Shore Drive, Suite 1028, Chicago, IL 60611
    • Corresponding Author InformationAddress correspondence to: V.A.B.
  • ,
  • Ameer Gomberawalla, MS

      Affiliations

    • Northwestern University Feinberg School of Medicine, Chicago, IL
  • ,
  • Michelle Chambers, MS, PA

      Affiliations

    • Northwestern Memorial Hospital, Northwestern Orthopedic Institute, Chicago, IL§
  • ,
  • Mark Bowen, MD

      Affiliations

    • Orthopedic Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL
  • ,
  • Gordon Nuber, MD

      Affiliations

    • Orthopedic Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL

Received 9 June 2009 ,Accepted 24 February 2010.

References 

  1. Centers for Disease Control and Prevention and National Institutes of Health. Healthy People 2010 (Arthritis, Osteoporosis, and Chronic Back Conditions). http://www.healthypeople.gov/document/html/Volume1/ 02Arthritis.htmAccessed November 10, 2009
  2. Wofford JL, Mansfield RJ, Watkins RS. Patient characteristics and clinical management of patients with shoulder pain in U.S. primary care settings: secondary data analysis of the National Ambulatory Medical Care Survey. BMC Musculoskelet Disord. 2005;6:4
  3. Reineck JR, Krishnan SG, Burkhead WZ. Early glenohumeral arthritis in the competing athlete. Clin Sports Med. 2008;27:803–819
  4. Meislin RJ, Sperling JW, Stitik TP. Persistent shoulder pain: Epidemiology, pathophysiology, and diagnosis. Am J Orthop. 2005;34:5–9
  5. Millett PJ, Gobezie R, Boykin RE. Shoulder osteoarthritis: Diagnosis and management. Am Fam Physician. 2008;78:605–611
  6. Burbank KM, Stevenson JH, Czarnecki GR, Dorfman J. Chronic shoulder pain: Part II (Treatment). Am Fam Physician. 2008;77:493–497
  7. American Academy of Orthopaedic Surgeons. Shoulder joint replacement. http://orthoinfo.aaos.org/topic.cfm?topic=A00094Accessed August 26, 2009
  8. van Baar ME, Assendelft WJ, Dekker J, Oostendorp RA, Bijlsma JW. Effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: A systematic review of randomized clinical trials. Arthritis Rheum. 1999;42:1361–1369
  9. Iannotti JP, Kwon YW. Management of persistent shoulder pain: A treatment algorithm. Am J Orthop. 2005;34:16–23
  10. Moskowitz RW, Blaine TA. An overview of treatment options for persistent shoulder pain. Am J Orthop. 2005;34:10–15
  11. Smidt N, de Vet HC, Bouter LM, et al. Effectiveness of exercise therapy: a best-evidence summary of systematic reviews. Aust J Physiother. 2005;51:71–85
  12. Synvisc® (hylan G-F 20) Product Information. Cambridge, MA: Genzyme Biosurgery.
  13. Hyalgan® (sodium hyaluronate) Product Information. Padua, Italy: Fidia Farmaceutici S.p.A.
  14. Supartz® (sodium hyaluronate) Product Information. Tokyo, Japan: Seikagaku Corporation.
  15. Orthovisc® (sodium hyaluronate) Product Information. Woburn, MA: Anika Pharmaceuticals.
  16. Euflexxa® (1% sodium hyaluronate) Product Information. Parsippany, NJ: Ferring Pharmaceuticals.
  17. Altman R, Alarcon G, Appelrouth D, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum. 1991;34:505–514
  18. Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957;16:494–502
  19. Kirkley A, Alvarez C, Griffin S. The development and evaluation of a disease-specific quality-of-life questionnaire for disorders of the rotator cuff: The Western Ontario Rotator Cuff Index. Clin J Sport Med. 2003;13:84–92
  20. Tubach F, Ravaud P, Beaton D, et al. Minimal clinically important improvement and patient acceptable symptom state for subjective outcome measures in rheumatic disorders. J Rheumatol. 2007;34:1188–1193
  21. Angst F, Aeschlimann A, Michel BA, Stucki G. Minimal clinically important rehabilitation effects in patients with osteoarthritis of the lower extremities. J Rheumatol. 2002;29:131–138
  22. Ehrich EW, Davies GM, Watson DJ, Bolognese JA, Seidenberg BC, Bellamy N. Minimal perceptible clinical improvement with the Western Ontario and McMaster Universities osteoarthritis index questionnaire and global assessments in patients with osteoarthritis. J Rheumatol. 2000;27:2635–2641
  23. van de Sande MA, Brand R, Rozing PM. Indications, complications, and results of shoulder arthroplasty. Scand J Rheumatol. 2006;35:426–434
  24. Sperling JW, Cofield RH, Rowland CM. Neer hemiarthroplasty and Neer total shoulder arthroplasty in patients fifty years old or less (Long-term results). J Bone Joint Surg Am. 1998;80:464–473
  25. Sperling JW, Antuna SA, Sanchez-Sotelo J, Schleck C, Cofield RH. Shoulder arthroplasty for arthritis after instability surgery. J Bone Joint Surg Am. 2002;84-A:1775–1781
  26. Sperling JW, Cofield RH, Rowland CM. Minimum fifteen-year follow-up of Neer hemiarthroplasty and total shoulder arthroplasty in patients aged fifty years or younger. J Shoulder Elbow Surg. 2004;13:604–613
  27. Bishop JY, Flatow EL. Humeral head replacement versus total shoulder arthroplasty: clinical outcomes–a review. J Shoulder Elbow Surg. 2005;14:141S–146S
  28. Stitik TP, Kumar A, Foye PM. Corticosteroid injections for osteoarthritis. Am J Phys Med Rehabil. 2006;85:S51–S65
  29. Caldwell JR. Intra-articular corticosteroids (Guide to selection and indications for use). Drugs. 1996;52:507–514
  30. Caborn D, Rush J, Lanzer W, Parenti D, Murray C. A randomized, single-blind comparison of the efficacy and tolerability of hylan G-F 20 and triamcinolone hexacetonide in patients with osteoarthritis of the knee. J Rheumatol. 2004;31:333–343
  31. Shapiro PS, Rohde RS, Froimson MI, Lash RH, Postak P, Greenwald AS. The effect of local corticosteroid or ketorolac exposure on histologic and biomechanical properties of rabbit tendon and cartilage. Hand (N Y). 2007;2:165–172
  32. Celeste C, Ionescu M, Robin PA, Laverty S. Repeated intraarticular injections of triamcinolone acetonide alter cartilage matrix metabolism measured by biomarkers in synovial fluid. J Orthop Res. 2005;23:602–610
  33. Haddad IK. Temporomandibular joint osteoarthrosis (Histopathological study of the effects of intra-articular injection of triamcinolone acetonide). Saudi Med J. 2000;21:675–679
  34. Hochberg MC, Altman RD, Brandt KD, et al. Guidelines for the medical management of osteoarthritis (Part II. Osteoarthritis of the knee). Arthritis Rheum. 1995;38:1541–1546
  35. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Recommendations for the medical management of osteoarthritis of the hip and knee. Arthritis Rheum. 2000;43:1905–1915
  36. Balazs E. The physical properties of synovial fluid and the specific role of hyaluronic acid. In:  Helfet AJ editors. Disorders of the Knee. 2nd ed.. Philadelphia: JB Lippincott; 1982;p. 61–74
  37. Balazs EA. Medical applications of hyaluronan and its derivatives. In:  Gebelein CG editors. Cosmetic and Pharmaceutical Applications of Polymers. New York, NY: Plenum Press; 1991;p. 293–309
  38. Gomis A, Pawlak M, Balazs EA, Schmidt RF, Belmonte C. Effects of different molecular weight elastoviscous hyaluronan solutions on articular nociceptive afferents. Arthritis Rheum. 2004;50:314–326
  39. Moreland LW. Intra-articular hyaluronan (hyaluronic acid) and hylans for the treatment of osteoarthritis: mechanism of action. Arthritis Res Ther. 2003;5:54–67
  40. Jansen EJ, Emans PJ, Douw CM, et al. One intra-articular injection of hyaluronan prevents cell death and improves cell metabolism in a model of injured articular cartilage in the rabbit. J Orthop Res. 2008;26:624–630
  41. Akmal M, Singh A, Anand A, et al. The effects of hyaluronic acid on articular chondrocytes. J Bone Joint Surg. 2005;87:1143–1149
  42. Waddell DD, Kolomytkin OV, Dunn S, Marino AA. Hyaluronan suppresses IL-1beta-induced metalloproteinase activity from synovial tissue. Clin Orthop Relat Res. 2007;
  43. Wobig M, Dickhut A, Maier R, Vetter G. Viscosupplementation with hylan G-F 20: a 26-week controlled trial of efficacy and safety in the osteoarthritic knee. Clin Ther. 1998;20:410–423
  44. Kemper F, Gebhardt U, Meng T, Murray C. Tolerability and short-term effectiveness of hylan G-F 20 in 4253 patients with osteoarthritis of the knee in clinical practice. Curr Med Res Opin. 2005;21:1261–1269
  45. Waddell DD, Bricker D. Clinical experience with the effectiveness and tolerability of hylan G-F 20 in 1047 patients with osteoarthritis of the knee. J Knee Surg. 2006;19:19–27
  46. Leopold SS, Warme WJ, Pettis PD, Shott S. Increased frequency of acute local reaction to intra-articular hylan GF-20 (Synvisc) in patients receiving more than one course of treatment. J Bone Joint Surg Am. 2002;84-A:1619–1623
  47. Pullman-Mooar S, Mooar P, Sieck M, Clayburne G, Schumacher HR. Are there distinctive inflammatory flares after hylan g-f 20 intraarticular injections?. J Rheumatol. 2002;29:2611–2614
  48. Tahiri L, Benbouazza K, Amine B, Hajjaj-Hassouni N. Acute pseudoseptic arthritis after viscosupplementation of the knee: A case report. Clin Rheumatol. 2007;26:1977–1979
  49. Waddell DD. The tolerability of viscosupplementation: Low incidence and clinical management of local adverse events. Curr Med Res Opin. 2003;19:575–580
  50. Goldberg VM, Coutts RD. Pseudoseptic reactions to hylan viscosupplementation (Diagnosis and treatment). Clin Orthop. 2004;419:130–137
  51. Brzusek D, Petron D. Treating knee osteoarthritis with intra-articular hyaluronans. Curr Med Res Opin. 2008;24:3307–3322
  52. Ozturk C, Atamaz F, Hepguler S, Argin M, Arkun R. The safety and efficacy of intraarticular hyaluronan with/without corticosteroid in knee osteoarthritis: 1-year, single-blind, randomized study. Rheumatol Int. 2006;26:314–319
  53. Tekeoglu I, Adak B, Goksoy T, Tosun N. Effects of intra-articular injections of sodium hyaluronate (orthovisc) and betamethasone on osteoarthritis of the knee. J Rheumatol Med Rehab. 1998;9:220–224
  54. Grecomoro G, Piccione F, Letizia G. Therapeutic synergism between hyaluronic acid and dexamethasone in the intra-articular treatment of osteoarthritis of the knee: A preliminary open study. Curr Med Res Opin. 1992;13:49–55
  55. Silverstein E, Leger R, Shea KP. The use of intra-articular hylan G-F 20 in the treatment of symptomatic osteoarthritis of the shoulder: a preliminary study. Am J Sports Med. 2007;35:979–985
  56. Valiveti M, Reginato AJ, Falasca GF. Viscosupplementation for degenerative joint disease of shoulder and ankle. J Clin Rheumatol. 2006;12:162–163
  57. Shibata Y, Midorikawa K, Emoto G, Naito M. Clinical evaluation of sodium hyaluronate for the treatment of patients with rotator cuff tear. J Shoulder Elbow Surg. 2001;10:209–216
  58. Scale D, Wobig M, Wolpert W. Viscosupplementation of osteoarthritic knees with hylan: A treatment schedule study. Curr Ther Res. 1994;55:220–232

 Disclosure Key can be found on the Table of Contents and at www.pmrjournal.org

 This study was funded, in part, by an investigator-initiated grant from Genzyme Biosurgery, who also provided partial support to a medical writer for assistance in manuscript preparation.

PII: S1934-1482(10)00135-8

doi: 10.1016/j.pmrj.2010.02.010

PM&R
Volume 2, Issue 4 , Pages 259-267 , April 2010