Dataset Information

A Pilot Study on the Efficacy of a Single Intra-Articular Administration of Triamcinolone Acetonide, Hyaluronan, and a Combination of Both for Clinical Management of Osteoarthritis in Police Working Dogs.

ABSTRACT: Objectives: To describe and compare the use and effectiveness of a single intra-articular injection (IA) of triamcinolone acetonide (TA), hyaluronan (HA), and a combination of both (TA+HA) in police working dogs with natural occurring hip osteoarthritis (OA). Study Design: Prospective, randomized, single-blinded study. Sample Population: Thirty animals with naturally occurring hip OA. Methods: Animals were randomly divided in three groups: GT, treated with 20 mg of TA per hip joint; GH, treated with treated 20 mg of HA per hip joint; and GTH, treated with a combination of 20 mg of TA and 20 mg of HA per hip joint. Response to treatment, measured by the Canine Brief Pain Inventory (divided in Pain Interference Score-PIS and Pain Severity Score-PSS) and the Hudson Visual Analog Scale (HVAS), was evaluated in seven different time points: T0 (before treatment), T1 (after 15 days), T2, T3, T4, T5, and T6 (after 1, 2, 3, 4, and 5 months, respectively). Results were compared using a Kruskal-Wallis test or a Wilcoxon signed ranks test, and p < 0.05 was set. Results: Comparing results of the different time points considered with T0, significant differences were registered in GH at T1 for HVAS (p = 0.03) and PIS (p = 0.04); and in GTH at T1 (p = 0.05 for HVAS and p < 0.05 for PIS), T2 (p < 0.04 for PIS), T3 (p < 0.03 for HVAS and p = 0.05 for PIS), T4 (p < 0.03 for HVAS and p < 0.05), and T5 (p < 0.05 for HVAS). No significant differences were found between groups when comparing scores in each time point. Individual treatment is considered successful with a reduction of ?1 for PSS or ?2 for PIS. In GTH, treatment was successful in four animals between T1 and T5 (40%, n = 10) and three at T6-T7 (30%, n = 10) for PSS and three animals of GTH at T1 (30%), two at T2 (20%), three between T3 and T4 (30%), and two between T5 and T7 (20%). Conclusions and Clinical Relevance: This study provides direct information on the use of these treatment modalities in patients with hip OA. Intra-articular injection with TA and HA may be a treatment option for dogs with naturally occurring OA, particularly when simultaneously used, as they provide significant improvements of PIS and HVAS scores. Individual scores improved in some animals with PIS, PSS, and HVAS.

SUBMITTER: Alves JC

PROVIDER: S-EPMC7690322 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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A Pilot Study on the Efficacy of a Single Intra-Articular Administration of Triamcinolone Acetonide, Hyaluronan, and a Combination of Both for Clinical Management of Osteoarthritis in Police Working Dogs.

Alves João C JC Santos Ana A Jorge Patrícia P Lavrador Catarina C Carreira L Miguel LM

Frontiers in veterinary science 20201106

Objectives: To describe and compare the use and effectiveness of a single intra-articular injection (IA) of triamcinolone acetonide (TA), hyaluronan (HA), and a combination of both (TA+HA) in police working dogs with natural occurring hip osteoarthritis (OA). Study Design: Prospective, randomized, single-blinded study. Sample Population: Thirty animals with naturally occurring hip OA. Methods: Animals were randomly divided in three groups: GT, treated with 20 mg of TA ...[more]

PMID: 33282924

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Project description:BackgroundCartilage defects result in joint inflammation. The presence of proinflammatory factors has been described to negatively affect cartilage formation.PurposeTo evaluate the effect and timing of administration of triamcinolone acetonide (TAA), an anti-inflammatory drug, on cartilage repair using a mouse model.Study designControlled laboratory study.MethodsA full-thickness cartilage defect was created in the trochlear groove of 10-week-old male DBA/1 mice (N = 80). Mice received an intra-articular injection of TAA or saline on day 1 or 7 after induction of the defect. Mice were euthanized on days 10 and 28 for histological evaluation of cartilage defect repair, synovial inflammation, and synovial membrane thickness.ResultsMice injected with TAA had significantly less synovial inflammation at day 10 than saline-injected mice independent of the time of administration. At day 28, the levels of synovitis dropped toward healthy levels; nevertheless, the synovial membrane was thinner in TAA- than in saline-injected mice, reaching statistical significance in animals injected on day 1 (70.1 ± 31.9 µm vs 111.9 ± 30.9 µm, respectively; P = .01) but not in animals injected on day 7 (68.2 ± 21.86 µm vs 90.2 ± 21.29 µm, respectively; P = .26). A thinner synovial membrane was moderately associated with less filling of the defect after 10 and 28 days (r = 0.42, P = .02; r = 0.47, P = .01, respectively). Whereas 10 days after surgery there was no difference in the area of the defect filled and the cell density in the defect area between saline- and TAA-injected knees, filling of the defect at day 28 was lower in TAA- than in saline-injected knees for both injection time points (day 1 injection, P = .04; day 7 injection, P = .01). Moreover, there was less collagen type 2 staining in the filled defect area in TAA- than in saline-injected knees after 28 days, reaching statistical significance in day 1-injected knees (2.6% vs 18.5%, respectively; P = .01) but not in day 7-injected knees (7.4% vs 15.8%, respectively; P = .27).ConclusionIntra-articular injection of TAA reduced synovial inflammation but negatively affected cartilage repair. This implies that inhibition of inflammation may inhibit cartilage repair or that TAA has a direct negative effect on cartilage formation.Clinical relevanceOur findings show that TAA can inhibit cartilage defect repair. Therefore, we suggest not using TAA to reduce inflammation in a cartilage repair setting.

Project description:IntroductionSingle intra-articular (IA) injections of poly(lactic-co-glycolic acid) (PLGA) microsphere-based triamcinolone acetonide extended-release (TA-ER; formerly FX006) demonstrated sustained, clinically relevant benefits in patients with knee osteoarthritis. The local effects of TA-ER were assessed in normal canine knees in three nonclinical studies.MethodsKnees were evaluated for up to 6 weeks or 9 months after a single injection of TA-ER (2.1/6.25/18.75 mg TA), or TA crystalline suspension (TAcs, 18.75 mg TA), and for up to 6 months after three injections (every 1 or 3 months) of TA-ER (6.25/18.75 mg TA) or TAcs (18.75 mg). Vehicle-diluent, blank microspheres, and untreated knees were used as controls. Plasma and synovial fluid (SF) TA concentrations and standard histopathological assessment of the synovium were conducted. Articular cartilage morphology was assessed via modified Mankin scoring.ResultsPlasma and SF concentrations indicated prolonged dose-dependent TA joint residency with TA-ER compared with TAcs. Effects in articular cartilage were dose- and time-dependent and consistent with known effects of corticosteroids in the normal knee. Loss of Safranin O staining occurred, indicative of a reduction in cartilage matrix proteoglycan, and recovered in a similar manner for TA-ER and TAcs across all studies. Structural lesions were infrequent and generally comparable in severity between TA-ER and TAcs but slightly higher in incidence for TA-ER. Focal/multifocal foreign-body responses (FBR) to PLGA were observed in the superficial layer of the synovium, peaking after 4-6 weeks, with significant recovery or complete resolution by month 6.ConclusionsThese findings suggest that the effects of IA injections of TA-ER on cartilage are predominantly transient, and comparable to those observed with TAcs in the normal canine knee joint. These mild effects in the normal joint differ from the beneficial effects observed with TA-ER and other corticosteroids in disease models. The synovial FBR to PLGA microspheres was focal and transient.FundingFlexion Therapeutics, Inc. Plain language summary available for this article.

Project description:ObjectiveWhile the effect of triamcinolone acetonide extended-release (TA-ER) on reducing knee osteoarthritis (OA) pain has been reported, the effects on physical performance are incompletely understood. This open label clinical trial systematically evaluated the effects of intra-articular TA-ER on physical performance, self-reported function, and quality of life in participants with bilateral symptomatic knee OA 6, 12 (primary) and 24 weeks following bilateral injection of TA-ER (32 mg).MethodsSeventy participants were enrolled (61.4% women; age 64.0 ± 11.7; BMI 31.8 ± 5.7 kg/m2). Physical performance was measured by 30-s chair stand test, 40 m fast paced walk test (FPWT), and stair negotiation test at baseline and each follow-up visit. Physical function and quality of life (QOL) were measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS-PS) and pain was measured with numeric rating scale (NRS).ResultsIn comparison with baseline, self-reported pain, function, and quality of life were improved at each follow-up through 24 weeks and the number of chair-stands significantly improved following treatment by (mean ± SE) 1.9 ± 0.6 at 6-week (p = 0.0048) and by 1.8 ± 0.5 at 12-week follow-up (p = 0.0011) but was not statistically significant at 24-week follow-up (0.6 ± 0.6; p = 0.4711). Stair negotiation times were 7.2 ± 3.7, 7.1 ± 3.8, and 5.4 ± 4.0 s lower at the three respective follow-up timepoints, although these changes did not reach statistical significance (p = 0.0530, p = 0.0599, and p = 0.1793 respectively). The 40m-FPWT time did not significantly improve.ConclusionThese data indicate improvement in chair stand performance through 12 weeks post-injection and sustained improvement in participant-reported physical function through 24-week follow-up in adults with bilateral painful knee OA treated with TA-ER.

Project description:BACKGROUND:Intra-articular corticosteroids relieve osteoarthritis pain, but rapid systemic absorption limits efficacy. FX006, a novel, microsphere-based, extended-release triamcinolone acetonide (TA) formulation, prolongs TA joint residence and reduces systemic exposure compared with standard TA crystalline suspension (TAcs). We assessed symptomatic benefits and safety of FX006 compared with saline-solution placebo and TAcs. METHODS:In this Phase-3, multicenter, double-blinded, 24-week study, adults ?40 years of age with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) and average-daily-pain (ADP)-intensity scores of ?5 and ?9 (0 to 10 numeric rating scale) were centrally randomized (1:1:1) to a single intra-articular injection of FX006 (32 mg), saline-solution placebo, or TAcs (40 mg). The primary end point was change from baseline to week 12 in weekly mean ADP-intensity scores for FX006 compared with saline-solution placebo. Secondary end points were area-under-effect (AUE) curves of the change in weekly mean ADP-intensity scores from baseline to week 12 for FX006 compared with saline-solution placebo, AUE curves of the change in weekly mean ADP-intensity scores from baseline to week 12 for FX006 compared with TAcs, change in weekly mean ADP-intensity scores from baseline to week 12 for FX006 compared with TAcs, and AUE curves of the change in weekly mean ADP-intensity scores from baseline to week 24 for FX006 compared with saline-solution placebo. Exploratory end points included week-12 changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS-QOL) subscale scores for FX006 compared with saline-solution placebo and TAcs. Adverse events were elicited at each inpatient visit. RESULTS:The primary end point was met. Among 484 treated patients (n = 161 for FX006, n = 162 for saline-solution placebo, and n = 161 for TAcs), FX006 provided significant week-12 improvement in ADP intensity compared with that observed for saline-solution placebo (least-squares mean change from baseline: -3.12 versus -2.14; p < 0.0001) indicating ?50% improvement. FX006 afforded improvements over saline-solution placebo for all secondary and exploratory end points (p < 0.05). Improvements in osteoarthritis pain were not significant for FX006 compared with TAcs using the ADP-based secondary measures. Exploratory analyses of WOMAC-A, B, and C and KOOS-QOL subscales favored FX006 (p ? 0.05). Adverse events were generally mild, occurring at similar frequencies across treatments. CONCLUSIONS:FX006 provided significant, clinically meaningful pain reduction compared with saline-solution placebo at week 12 (primary end point). LEVEL OF EVIDENCE:Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Dataset Information

A Pilot Study on the Efficacy of a Single Intra-Articular Administration of Triamcinolone Acetonide, Hyaluronan, and a Combination of Both for Clinical Management of Osteoarthritis in Police Working Dogs.

Publications

A Pilot Study on the Efficacy of a Single Intra-Articular Administration of Triamcinolone Acetonide, Hyaluronan, and a Combination of Both for Clinical Management of Osteoarthritis in Police Working Dogs.

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