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”)

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

Effect of a Collagen-Based Compound on Morpho-Functional Properties of Cultured Human Tenocytes

“…A limit of this study is represented by the lacking of studies aimed at characterizing the permanence and rheological and visco-elastic properties of MD-Tissue, however clinical studies are available demonstrating that the collagen-based medical compound is effective in osteoarticular pathologies [18,19].…”

“…No side effects, allergic reactions, nor drug interactions have been observed. Clinical data reported that treatment with MD-Knee, a collagen-based medical compound similar to MD-Tissue, for up to 6 months was generally well tolerated, and no systemic adverse events or septic complications were observed [18,19].…”

Intra-Articular Injection of Hydrolyzed Collagen to Treat Symptoms of Knee Osteoarthritis. A Functional In Vitro Investigation and a Pilot Retrospective Clinical Study

“…The first, by Furuzawa-Carballeda et al [20,21], showed a statistically significant improvement on VAS, WOMAC, and Lequesne indexes after 12 bi-weekly intra-articular injections of 2 mL (13.8 mg) pepsin-treated porcine polymerized, type I collagen versus as many placebo injections. More recently, a double-blind randomized controlled clinical trial on 29 patients [22] showed no significant differences in VAS and Lequesne scores at 3 or 6 months after treatment, in patients that were administered five intra-articular injections of 4 mL (concentration unknown) 300 kDa type I hydrolyzed porcine collagen at 1-week intervals versus patients that were given as many injections of 2.5 mL (25 mg) sodium hyaluronate. Recently, a novel injectable collagen formulation (ChondroGrid (CG), Bioteck, Arcugnano, Italy) consisting of bovine hydrolyzed <3 kDa type I collagen (4 mg/2 mL) has been developed and is currently available on the market as an injectable medical device.…”

Long-Term Effectiveness of Polymerized-Type I Collagen Intra-Articular Injections in Patients with Symptomatic Knee Osteoarthritis: Clinical and Radiographic Evaluation in a Cohort Study

“…On the other hand, its degradation in the constituent amino acids constitutes a nutritional support for tissues of the other joint structures. MD-Knee preparation is equally effective in knee OA symptoms over six months after a five-week injection course as the HA formulation (SUPARTZ ® ) [32]. Moreover, 3 mL IAI of porcine type I atelocollagen (BioCollagen group) has been also demonstrated to alleviate knee pain in OA patients at 24 weeks [33].…”