Abstract
BackgroundTo 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.MethodThis 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.ResultsAt 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.ConclusionsThis 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 registrationTrial registration number: ISRCTN93862496. Registration date: January 18th, 2016
Highlights
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
At the 3- and 6 month follow-up, Lequesne Knee Index (LKI) and Visual Analogue Scale (VAS) improved significantly in both groups compared to baseline and no statistically significant differences were observed between Group A and Group B
MD-Knee is effective on knee OA symptoms over 6 months after a 5-weekly injection course, and it is effective as the reference sodium hyaluronate
Summary
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. Osteoarthritis (OA) is a chronic degenerative joint disease characterized by progressive damage of articular cartilage and underlying bone. A medical device MD-Knee, produced by Guna S.p.a., Milan-Italy containing collagen of porcine origin has been investigated. Collagen content in MD-Knee has a molecular weight equal to 300,000 dalton, produced through a process of tangential filtration. It is a pure product, contaminant-free, with standardized chemical and physical characteristics. Porcine tissues have a very high average collagen content, around 50 %. Its degradation in the constituent aminoacids seems to constitute a nutritional support for tissues of the other joint structures [16–19]
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