PMID- 30223023 OWN - NLM STAT- MEDLINE DCOM- 20200316 LR - 20200316 IS - 1522-9653 (Electronic) IS - 1063-4584 (Linking) VI - 27 IP - 1 DP - 2019 Jan TI - Evaluating the use of intra-articular injections as a treatment for painful hip osteoarthritis: a randomized, double-blind, multicenter, parallel-group study comparing a single 6-mL injection of hylan G-F 20 with saline. PG - 59-70 LID - S1063-4584(18)31457-2 [pii] LID - 10.1016/j.joca.2018.08.018 [doi] AB - OBJECTIVE: Hip osteoarthritis (OA) is difficult to treat. Steroid injections reduce pain with short duration. With widespread adoption of office-based, image-guided injections, hyaluronic acid is a potentially relevant therapy. In the largest clinical trial to-date, we compared safety/efficacy of a single, 6-mL image-guided injection of hylan G-F 20 to saline in painful hip OA. METHOD: 357 patients were enrolled in a multicenter, double-blind, randomized saline placebo- controlled trial. Subjects were >/=35 years of age, with painful (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]-A1:5.0-8.0; numeric rating scale [NRS]: 0-10) mild-to-moderate hip OA (Kellgren-Lawrence grade II/III) and minimal contralateral hip pain (WOMAC-A1 < 4). Outcome measures included "pain on walking" (WOMAC-A1 and -A), Patient Global Self-Assessment (PTGA), WOMAC-A1 responder rate (+>/=2 points on NRS), and adverse events (AEs) over 26 weeks. RESULTS: 357 patients (hylan G-F 20 single:182; saline:175) were enrolled. Both groups demonstrated significant pain improvement from baseline over 26 weeks (P < 0.0001); saline-induced pain reduction was a remarkable 35%. WOMAC-A and PTGA scores also significantly improved (P < 0.0001). No statistically significant difference was observed between groups in WOMAC-A1 scores (hylan G-F 20 single:-2.19 +/- 0.16; saline:-2.26 +/- 0.17) or WOMAC-A1 responders (41-52%). Treatment-related AE rates at target hip were similar (hylan G-F 20 single:23 patients [12.8%]; saline:12 [7.0%]). Posthoc analysis found, despite protocol requirements, many patients had psychological (31%) or potential neuropathic pain (27.5%) conditions. CONCLUSION: A single 6-mL hylan G-F 20 injection or saline for painful hip OA resulted in similar, statistically significant/clinically relevant pain and function improvements up to 6 months following injection; no differences between hylan G-F 20 and saline placebo were observed. CI - Copyright (c) 2018. Published by Elsevier Ltd. FAU - Brander, V AU - Brander V AD - Northwestern University Feinberg School of Medicine, Chicago, IL, USA. Electronic address: vabrander@gmail.com. FAU - Skrepnik, N AU - Skrepnik N AD - Tucson Orthopaedic Institute, Tucson, AZ, USA. Electronic address: NSkrepnik@tucsonortho.com. FAU - Petrella, R J AU - Petrella RJ AD - Schulich School of Medicine and Dentistry, University of Western Ontario-London, Ontario, Canada. Electronic address: petrella@uwo.ca. FAU - Jiang, G-L AU - Jiang GL AD - Sanofi, R&D, Cambridge, MA, USA. Electronic address: Leon.Jiang@sanofi.com. FAU - Accomando, B AU - Accomando B AD - Sanofi, R&D, Cambridge, MA, USA. Electronic address: Beverly.Accomando@sanofi.com. FAU - Vardanyan, A AU - Vardanyan A AD - Sanofi, R&D, Cambridge, MA, USA. Electronic address: Anna.Vardanyan@sanofi.com. LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20180914 PL - England TA - Osteoarthritis Cartilage JT - Osteoarthritis and cartilage JID - 9305697 RN - 0 (Anti-Inflammatory Agents, Non-Steroidal) RN - 0 (Saline Solution) RN - 0 (Viscosupplements) RN - 125935-84-4 (hylan) RN - 362O9ITL9D (Acetaminophen) RN - 9004-61-9 (Hyaluronic Acid) SB - IM MH - Acetaminophen/therapeutic use MH - Aged MH - Anti-Inflammatory Agents, Non-Steroidal/therapeutic use MH - Double-Blind Method MH - Drug Therapy, Combination MH - Female MH - Humans MH - Hyaluronic Acid/administration & dosage/adverse effects/*analogs & derivatives/therapeutic use MH - Injections, Intra-Articular MH - Male MH - Middle Aged MH - Osteoarthritis, Hip/complications/*drug therapy MH - Pain/etiology MH - Pain Measurement/methods MH - Saline Solution MH - Severity of Illness Index MH - Viscosupplements/*administration & dosage/adverse effects/therapeutic use MH - Walking OTO - NOTNLM OT - Hip osteoarthritis OT - Hylan G-F 20 OT - Intra-articular injections OT - Osteoarthritis OT - Synvisc-one EDAT- 2018/09/18 06:00 MHDA- 2020/03/17 06:00 CRDT- 2018/09/18 06:00 PHST- 2017/03/10 00:00 [received] PHST- 2018/07/25 00:00 [revised] PHST- 2018/08/06 00:00 [accepted] PHST- 2018/09/18 06:00 [pubmed] PHST- 2020/03/17 06:00 [medline] PHST- 2018/09/18 06:00 [entrez] AID - S1063-4584(18)31457-2 [pii] AID - 10.1016/j.joca.2018.08.018 [doi] PST - ppublish SO - Osteoarthritis Cartilage. 2019 Jan;27(1):59-70. doi: 10.1016/j.joca.2018.08.018. Epub 2018 Sep 14.