A double blind randomized active-controlled clinical trial on the intra-articular use of Md-Knee versus sodium hyaluronate in patients with knee osteoarthritis ("Joint")

Luis Severino Martin Martin, Umberto Massafra, Emanuele Bizzi, Alberto Migliore, Luis Severino Martin Martin, Umberto Massafra, Emanuele Bizzi, Alberto Migliore

Abstract

Background: To evaluate the clinical outcomes of a group of patients affected by knee osteoarthritis (OA) treated with MD-Knee (Guna S.p.a., Milan, Italy) versus a group of patients treated with sodium hyaluronate.

Method: This non-inferiority prospective randomized controlled trial involved 60 patients affected by knee OA, grade 2-3 of Kellgren-Lawrence scale. The MD-Knee Group, Group A (n = 29) was administered five intra-articular injections at 1 week interval; the sodium hyaluronate Group, Group B (n = 31), was administered five doses of intra-articular injection of sodium hyaluronate at 1 week interval. All patients were prospectively evaluated before and at 3 and 6 months after the treatment by the Lequesne Knee Index (LKI) as primary endpoint and the Visual Analogue Scale (VAS), Pain Killer consumption and SF-36 questionnaires as secondary endpoints.

Results: At the 3- and 6 month follow-up, LKI and VAS improved significantly in both groups compared to baseline and no statistically significant differences were observed between Group A and Group B. There was no statistically significant difference in the SF36 questionnaire score and pain killer consumption between two groups at any time point.

Conclusions: This study shows that both preparations exert similar clinical effects as assessed through multiple outcome measures. MD-Knee is effective on knee OA symptoms over 6 months after a 5-weekly injection course, and it is equally effective as the reference sodium hyaluronate.

Trial registration number: ISRCTN93862496 . Registration date: January 18th, 2016.

Figures

Fig. 1
Fig. 1
Flow chart reporting patients’ enrollment and study prosecution with drop outs and reasons for drop out
Fig. 2
Fig. 2
Variation of LKI (Lequesne Knee Index) score intra-subject and inter-groups at time T0; T3FU; T6FU
Fig. 3
Fig. 3
Visual Analogue Scale (VAS) at time T0; T3FU; T6FU for Group ARTZ® and in Group MD-Knee
Fig. 4
Fig. 4
SF36 questionnaire. Score at time T0; T3FU; T6FU for Group ARTZ®and Group MD-Knee
Fig. 5
Fig. 5
a Pain Killer consumption (days), in users only, in both groups. b Pain Killer consumption (days),in all subject, in both groups

References

    1. Pereira D, Peleteiro B, Araujo J, et al. The effect of osteoarthritis definition on prevalence and incidence estimates: a systematic review. Osteoarthr. Cartil. 2011;19:1270–85. doi: 10.1016/j.joca.2011.08.009.
    1. Bijlsma JW, Berenbaum F, Lafeber FP. Osteoarthritis: an update with relevance for clinical practice. Lancet. 2011;377:2115–26. doi: 10.1016/S0140-6736(11)60243-2.
    1. Dougados M, Hochberg MC. Management of osteoarthritis. In: Hochberg MC, Silman AJ, Smolen JS, Weinblatt ME, Weisman M, editors. Rheumatology. 5. Philadelphia: Mosby/ Elsevier; 2011. pp. 1793–9.
    1. Wang CT, Lin J, Chang CJ, Lin YT, Hou SM. Therapeutic effects of hyaluronic acid on osteoarthritis of the knee. A meta-analysis of randomized controlled trials. J Bone Joint Surg Am. 2004;86-A:538–545.
    1. Bellamy N, Campbell J, Robinson V, Gee T, Bourne R, Wells G. Viscosupplementation for the treatment of osteoarthritis of the knee. Cochrane Database Syst Rev. 2006;2:CD005321.
    1. Goldberg VM, Buckwalter JA. Hyaluronans in the treatment of osteoarthritis of the knee: evidence for disease-modifying activity. Osteoarthr. Cartil. 2005;13(3):216–24. doi: 10.1016/j.joca.2004.11.010.
    1. Divine JG, Shaffer MD. Use of viscosupplementation for knee osteoarthritis: an update. Curr Sports Med Rep. 2011;10:279–284. doi: 10.1249/JSR.0b013e31822ed1b4.
    1. Becker LC, Bergfeld WF, Belsito DV, Klaassen CD, Marks JG, Shank RC, et al. Final report of the safety assessment of hyaluronic acid, potassium hyaluronate, and sodium hyaluronate. Int J Toxicol. 2009;28:5–67. doi: 10.1177/1091581809337738.
    1. Wu JJ, Shih LY, Hsu HC, Chen TH. The double-blind test of sodium hyaluronate (ARTZ) on osteoarthritis knee. Zhonghua Yi Xue Za Zhi. 1997;59:99–106.
    1. Sun SF, Chou YJ, Hsu CW, Chen WL. Hyaluronic acid as a treatment for ankle osteoarthritis. Curr Rev Musculoskelet Med. 2009;2(2):78–82. doi: 10.1007/s12178-009-9048-5.
    1. Migliore A, Granata M. Intra-articular use of hyaluronic acid in the treatment of osteoarthritis. Clin Interv Aging. 2008;3(2):365–9.
    1. Curran MP. Hyaluronic acid (Supartz®): a review of its use in osteoarthritis of the knee. Drugs Aging. 2010;27(11):925–41. doi: 10.2165/11205920-000000000-00000.
    1. Strand V, Conaghan PG, Lohmander LS, et al. An integrated analysis of five double-blind, randomized controlled trials evaluating the safety and efficacy of a hyaluronan product for intra-articular injection in osteoarthritis of the knee. Osteoarthr. Cartil. 2006;14(9):859–866. doi: 10.1016/j.joca.2006.02.012.
    1. Goldberg VM, Goldberg L. Intra-articular hyaluronans: the treatment of knee pain in osteoarthritis. J Pain Res. 2010;3:51–6. doi: 10.2147/JPR.S4733.
    1. Sun SF, Hsu CW, Hwang CW, et al. Hyaluronate improves pain, physical function and balance in the geriatric osteoarthritic knee: a 6-month follow-up study using clinical tests. Osteoarthr. Cartil. 2006;14(7):696–701. doi: 10.1016/j.joca.2006.01.010.
    1. Di Cesare ML, Micheli L, Zanardelli M, Ghelardini C. Low dose native type II collagen prevents pain in a rat osteoarthritis model. BMC Musculoskelet Disord. 2013;14:228. doi: 10.1186/1471-2474-14-228.
    1. Naraoka T, Ishibashi Y, Tsuda E, Yamamoto Y, Kusumi T, Toh S. Periodic knee injections of collagen tripeptide delay cartilage degeneration in rabbit experimental osteoarthritis. Arthritis Res Ther. 2013;15(1):R32. doi: 10.1186/ar4181.
    1. Xiao D, Hu J, Chen K, Man C, Zhu S. Protection of articular cartilage by intra-articular injection of NEL-like molecule 1 in temporomandibular joint osteoarthritis. J Craniofac Surg. 2012;23(1):e55–8. doi: 10.1097/SCS.0b013e3182418d02.
    1. Milani L. Un nuovo e raffinato trattamento iniettivo delle patologie algiche dell’Apparato locomotore. Le proprietà bio-scaffold del collagene e suo utilizzo clinico. La Med Biol. 2010;3:3–15.
    1. Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, et al. OMERACT-OARSI initiative: osteoarthritis research society international set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthr. Cartil. 2004;12(5):389–99. doi: 10.1016/j.joca.2004.02.001.

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi