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BMC Musculoskelet Disord. 2016 Feb 22;17:94. doi: 10.1186/s12891-016-0948-4.

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").

Author information

1
Department of Internal Medicine, "Regina Apostolorum" Hospital, Via S. Francesco 50, Albano Laziale, Rome, Italy.
2
Operative Unit of Rheumatology "S.Pietro-Fatebenefratelli" Hospital, Via Cassia 600, 00189, Rome, Italy.
3
Operative Unit of Rheumatology "S.Pietro-Fatebenefratelli" Hospital, Via Cassia 600, 00189, Rome, Italy. bizzi.emanuele@gmail.com.

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:

TRIAL REGISTRATION NUMBER:

ISRCTN93862496 . Registration date: January 18th, 2016.

PMID:
26905565
PMCID:
PMC4763423
DOI:
10.1186/s12891-016-0948-4
[Indexed for MEDLINE]
Free PMC Article

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