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Randomized controlled trial demonstrates the benefit of RGTA® based matrix therapy to treat tendinopathies in racing horses.

ABSTRACT: A randomized controlled trial was performed on racing horses, to evaluate the efficacy of a new class of therapeutic agents in regenerative medicine-ReGeneraTing Agents® (RGTA®), to treat tendinopathies. Preliminary uncontrolled studies on tendon healing in racing horses with RGTA® (OTR4131)-Equitend® showed encouraging results, justifying performing a randomized, controlled, multicenter study with a two-year racing performance follow up. The objective of this study was to evaluate the effect of Equitend® versus placebo on acute superficial digital flexor tendonitis in racing French Standardbred Trotters (ST). Twenty-two ST were randomly and blindly assigned to receive with a ratio of 2 to 1, a single Equitend® (n = 14) or placebo (n = 8) intralesional injection under ultrasonographic guidance. Horses were evaluated over 4 months, by clinical and ultrasonographic evaluations (day 0, months 1, 2, 4), and their racing performances followed up over the 2 years after treatment. During the first month of treatment, a significant decrease in the cross-sectional area (CSA) was found in the Equitend® group (p = 0.04). After 4 months, the number of Equitend® treated horses with an improved CSA was significantly higher than the placebo-treated horses (p = 0.03571). The Equitend® group returned to their pre-injury performance level, racing in, and winning, significantly more races than the placebo group (p = 0.01399 and 0.0421, respectively). Furthermore, recurrence was significantly higher in the placebo group than in the Equitend® group (71.4% vs 16.6%, p = 0.02442). In conclusion, we measured a significant, short-term, reduction effect on CSA and demonstrated a long-term beneficial effect of intralesional injection of Equitend® for the treatment of superficial digital flexor tendonitis on racing ST, racing 2. 3 times more often than placebo, with 3.3 times fewer recurrences maintaining pre-injury performance level. This study may open the way for the development of a human treatment of tendonitis.

SUBMITTER: Jacquet-Guibon S

PROVIDER: S-EPMC5844532 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Randomized controlled trial demonstrates the benefit of RGTA® based matrix therapy to treat tendinopathies in racing horses.

Jacquet-Guibon Sandrine S Dupays Anne-Gaelle AG Coudry Virginie V Crevier-Denoix Nathalie N Leroy Sandrine S Siñeriz Fernando F Chiappini Franck F Barritault Denis D Denoix Jean-Marie JM

PloS one 20180309 3

A randomized controlled trial was performed on racing horses, to evaluate the efficacy of a new class of therapeutic agents in regenerative medicine-ReGeneraTing Agents® (RGTA®), to treat tendinopathies. Preliminary uncontrolled studies on tendon healing in racing horses with RGTA® (OTR4131)-Equitend® showed encouraging results, justifying performing a randomized, controlled, multicenter study with a two-year racing performance follow up. The objective of this study was to evaluate the effect of ...[more]

PMID: 29522564

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Project description:BackgroundFor medication control in several jurisdictions, withdrawal time is the period of refrain from racing after drug administration. It is set by adding a safety period to an experimental detection time. However, there are no reports of statistical analyses of detection time for the determination of withdrawal time in flunixin meglumine-treated horses.ObjectiveTo analyse the population pharmacokinetics of flunixin in horses through the generation of a dataset for detection time statistical analysis and predictions via Monte Carlo simulation.Study designExperimental study.MethodsDrug plasma and urine concentrations following single intravenous administration of flunixin 1.1 mg/kg bodyweight (BW) in 10 horses and multiple administration of q 24 hours for 5 days in 10 horses were measured using liquid chromatography with tandem mass spectrometry (LC-MS/MS). Data were modelled using a nonlinear mixed effect model followed by Monte Carlo simulation. Irrelevant plasma concentration (IPC) and irrelevant urine concentration (IUC) were calculated using the Toutain approach. Detection times were obtained considering the time after the last administration for selected quantiles of 5000 hypothetical horses under the international screening limit (ISL) proposed by the International Federation of Horseracing Authorities (plasma: 1 ng/mL, urine; 100 ng/mL).ResultsFor a regimen of 1.1 mg/kg BW q 24 hours, the IPC and IUC values were 2.0 and 73.0 ng/mL respectively. Detection times in plasma above the ISL for 90% of simulated horses were estimated as 74 hours after a single 1.1 mg/kg dose administration, 149 and 199 hours after multiple doses over 5 days at either 24- or 12-hour intervals respectively. Corresponding detection times in urine were 46, 68 and 104 hours respectively.Main limitationOnly female horses were investigated.ConclusionsStatistical detection times for different flunixin meglumine regimens indicated a delay of detection time in plasma after multiple administrations under ISL.

Project description:BackgroundExtracorporeal shock-wave therapy (ESWT), which can be divided into radial shock-wave therapy (RaSWT) and focused shock-wave therapy (FoSWT), has been widely used in clinical practice for managing orthopedic conditions. The aim of this study was to determine the clinical efficacy of ESWT for knee soft tissue disorders (KSTDs) and compare the efficacy of different shock-wave types, energy levels, and intervention durations.MethodsWe performed a comprehensive search of online databases and search engines without restrictions on the publication year or language. We selected randomized controlled trials (RCTs) reporting the efficacy of ESWT for KSTDs and included them in a meta-analysis and risk of bias assessment. The pooled effect sizes of ESWT were estimated by computing odds ratios (ORs) with 95% confidence intervals (CIs) for the treatment success rate (TSR) and standardized mean differences (SMDs) with 95% CIs for pain reduction (i.e., the difference in pain relief, which was the change in pain from baseline to the end of RCTs between treatment and control groups) and for restoration of knee range of motion (ROM).ResultsWe included 19 RCTs, all of which were of high or medium methodological quality and had a Physiotherapy Evidence Database score of ≥5/10. In general, ESWT had overall significant effects on the TSR (OR: 3.36, 95% CI: 1.84-6.12, P < 0.0001), pain reduction (SMD: - 1.49, 95% CI: - 2.11 to - 0.87, P < 0.00001), and ROM restoration (SMD: 1.76, 95% CI: 1.43-2.09, P < 0.00001). Subgroup analyses revealed that FoSWT and RaSWT applied for a long period (≥1 month) had significant effects on pain reduction, with the corresponding SMDs being - 3.13 (95% CI: - 5.70 to - 0.56; P = 0.02) and - 1.80 (95% CI: - 2.52 to - 1.08; P < 0.00001), respectively. Low-energy FoSWT may have greater efficacy for the TSR than high-energy FoSWT, whereas the inverse result was observed for RaSWT.ConclusionsThe ESWT exerts an overall effect on the TSR, pain reduction, and ROM restoration in patients with KSTDs. Shock-wave types and application levels have different contributions to treatment efficacy for KSTDs, which must be investigated further for optimizing these treatments in clinical practice.

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Randomized controlled trial demonstrates the benefit of RGTA® based matrix therapy to treat tendinopathies in racing horses.

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Randomized controlled trial demonstrates the benefit of RGTA® based matrix therapy to treat tendinopathies in racing horses.

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