Tags

Type your tag names separated by a space and hit enter

Safety and performance of Hydros and Hydros-TA for knee osteoarthritis: a prospective, multicenter, randomized, double-blind feasibility trial.

Abstract

BACKGROUND

Studies have evaluated the concomitant use of hyaluronan (HA) with steroids, anti-inflammatory drugs and analgesic agents in an attempt to magnify the extent and duration of pain relief due to knee osteoarthritis. To date there has not been an intra-articular combination therapy available for relief of knee osteoarthritis symptoms--one that combines the fast acting onset of symptom relief provided by a corticosteroid with the long-lasting symptom relief provided by HA in a single injection. The objective of this study was to evaluate the safety and preliminary performance of two new HA formulations, Hydros (hyaluronan-based hydrogel suspended in hyaluronan solution) and Hydros-TA (HA plus 10 mg of triamcinolone acetonide [TA]) in subjects with knee osteoarthritis.

METHODS

We conducted a Phase 2 prospective, multicenter, randomized, double-blind feasibility trial. Participants (n = 98; mean age 60 years) with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) were randomized to three treatment groups: Hydros, Hydros-TA, and Synvisc-One® (hylan G-F 20). Participants received one 6 ml intra-articular injection in the treatment knee and were evaluated at 2, 6, 13, and 26 weeks post-treatment. Safety was assessed from adverse events at all study visits. The primary efficacy outcome was the change from baseline on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (Pain) score for the treatment knee.

RESULTS

Adverse events were similar across treatment groups with the most common being arthralgia, joint swelling, back pain, and joint stiffness. Arthralgia was reported 5 times with Synvisc-One, 4 with Hydros, and 1 with Hydros-TA. Each group demonstrated a reduction in the WOMAC A (Pain) score over 26 weeks: [least-square mean (standard error)] 30.5 (5.1) mm for Hydros; 34.4 (4.7) mm for Hydros-TA; 28.0 (5.4) mm for Synvisc-One and an observed improvement of 2.5 mm (p = 0.64) and 6.4 mm (p = 0.24) over Synvisc-One for Hydros and Hydros-TA, respectively.

CONCLUSIONS

A single injection of Hydros or Hydros-TA was well-tolerated and relieved pain associated with knee osteoarthritis over 26 weeks. Data indicate that Hydros-TA had a more rapid pain relief compared to Hydros alone. A Phase 3 trial is underway to confirm these preliminary results.

TRIAL REGISTRATION NUMBER

NCT01134406.

Authors+Show Affiliations

Aging, Rehabilitation & Geriatric Care Research Centre, Lawson Health Research Institute & Departments of Family Medicine, Kinesiology and Cardiology, Western University, London, Canada. petrella@uwo.ca.Department of Orthopaedic Surgery, Maastricht University Medical Center, Maastricht, the Netherlands. pj.emans@maastrichtuniversity.nl.Department of Family and Community Medicine, University of Toronto & Sport CARE, Women's College Hospital, Toronto, Canada. jkalleyne@crucible.net.Care to Move, St. Niklaas, Belgium. frank.dellaert@telenet.be.Aging, Rehabilitation & Geriatric Care Research Centre, Lawson Health Research Institute & Department of Family Medicine and School of Health Studies, Western University, London, Canada. dawn.gill@uwo.ca. Department of Epidemiology, University of Washington, Seattle, USA. dawn.gill@uwo.ca.Carbylan Therapeutics, Palo Alto, USA. mmaroney@carbylan.com.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25887932

Citation

Petrella, Robert J., et al. "Safety and Performance of Hydros and Hydros-TA for Knee Osteoarthritis: a Prospective, Multicenter, Randomized, Double-blind Feasibility Trial." BMC Musculoskeletal Disorders, vol. 16, 2015, p. 57.
Petrella RJ, Emans PJ, Alleyne J, et al. Safety and performance of Hydros and Hydros-TA for knee osteoarthritis: a prospective, multicenter, randomized, double-blind feasibility trial. BMC Musculoskelet Disord. 2015;16:57.
Petrella, R. J., Emans, P. J., Alleyne, J., Dellaert, F., Gill, D. P., & Maroney, M. (2015). Safety and performance of Hydros and Hydros-TA for knee osteoarthritis: a prospective, multicenter, randomized, double-blind feasibility trial. BMC Musculoskeletal Disorders, 16, p. 57. doi:10.1186/s12891-015-0513-6.
Petrella RJ, et al. Safety and Performance of Hydros and Hydros-TA for Knee Osteoarthritis: a Prospective, Multicenter, Randomized, Double-blind Feasibility Trial. BMC Musculoskelet Disord. 2015 Mar 18;16:57. PubMed PMID: 25887932.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and performance of Hydros and Hydros-TA for knee osteoarthritis: a prospective, multicenter, randomized, double-blind feasibility trial. AU - Petrella,Robert J, AU - Emans,Pieter J, AU - Alleyne,Julia, AU - Dellaert,Frank, AU - Gill,Dawn P, AU - Maroney,Marcee, Y1 - 2015/03/18/ PY - 2014/10/07/received PY - 2015/02/27/accepted PY - 2015/4/19/entrez PY - 2015/4/19/pubmed PY - 2016/2/26/medline SP - 57 EP - 57 JF - BMC musculoskeletal disorders JO - BMC Musculoskelet Disord VL - 16 N2 - BACKGROUND: Studies have evaluated the concomitant use of hyaluronan (HA) with steroids, anti-inflammatory drugs and analgesic agents in an attempt to magnify the extent and duration of pain relief due to knee osteoarthritis. To date there has not been an intra-articular combination therapy available for relief of knee osteoarthritis symptoms--one that combines the fast acting onset of symptom relief provided by a corticosteroid with the long-lasting symptom relief provided by HA in a single injection. The objective of this study was to evaluate the safety and preliminary performance of two new HA formulations, Hydros (hyaluronan-based hydrogel suspended in hyaluronan solution) and Hydros-TA (HA plus 10 mg of triamcinolone acetonide [TA]) in subjects with knee osteoarthritis. METHODS: We conducted a Phase 2 prospective, multicenter, randomized, double-blind feasibility trial. Participants (n = 98; mean age 60 years) with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) were randomized to three treatment groups: Hydros, Hydros-TA, and Synvisc-One® (hylan G-F 20). Participants received one 6 ml intra-articular injection in the treatment knee and were evaluated at 2, 6, 13, and 26 weeks post-treatment. Safety was assessed from adverse events at all study visits. The primary efficacy outcome was the change from baseline on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (Pain) score for the treatment knee. RESULTS: Adverse events were similar across treatment groups with the most common being arthralgia, joint swelling, back pain, and joint stiffness. Arthralgia was reported 5 times with Synvisc-One, 4 with Hydros, and 1 with Hydros-TA. Each group demonstrated a reduction in the WOMAC A (Pain) score over 26 weeks: [least-square mean (standard error)] 30.5 (5.1) mm for Hydros; 34.4 (4.7) mm for Hydros-TA; 28.0 (5.4) mm for Synvisc-One and an observed improvement of 2.5 mm (p = 0.64) and 6.4 mm (p = 0.24) over Synvisc-One for Hydros and Hydros-TA, respectively. CONCLUSIONS: A single injection of Hydros or Hydros-TA was well-tolerated and relieved pain associated with knee osteoarthritis over 26 weeks. Data indicate that Hydros-TA had a more rapid pain relief compared to Hydros alone. A Phase 3 trial is underway to confirm these preliminary results. TRIAL REGISTRATION NUMBER: NCT01134406. SN - 1471-2474 UR - https://www.unboundmedicine.com/medline/citation/25887932/Safety_and_performance_of_Hydros_and_Hydros_TA_for_knee_osteoarthritis:_a_prospective_multicenter_randomized_double_blind_feasibility_trial_ L2 - https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-015-0513-6 DB - PRIME DP - Unbound Medicine ER -