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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.
Osteoarthritis Cartilage. 2019 01; 27(1):59-70.OC

Abstract

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.

Authors+Show Affiliations

Northwestern University Feinberg School of Medicine, Chicago, IL, USA. Electronic address: vabrander@gmail.com.Tucson Orthopaedic Institute, Tucson, AZ, USA. Electronic address: NSkrepnik@tucsonortho.com.Schulich School of Medicine and Dentistry, University of Western Ontario-London, Ontario, Canada. Electronic address: petrella@uwo.ca.Sanofi, R&D, Cambridge, MA, USA. Electronic address: Leon.Jiang@sanofi.com.Sanofi, R&D, Cambridge, MA, USA. Electronic address: Beverly.Accomando@sanofi.com.Sanofi, R&D, Cambridge, MA, USA. Electronic address: Anna.Vardanyan@sanofi.com.

Pub Type(s)

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

Language

eng

PubMed ID

30223023

Citation

Brander, V, et al. "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." Osteoarthritis and Cartilage, vol. 27, no. 1, 2019, pp. 59-70.
Brander V, Skrepnik N, Petrella RJ, et al. 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. Osteoarthr Cartil. 2019;27(1):59-70.
Brander, V., Skrepnik, N., Petrella, R. J., Jiang, G. L., Accomando, B., & Vardanyan, A. (2019). 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. Osteoarthritis and Cartilage, 27(1), 59-70. https://doi.org/10.1016/j.joca.2018.08.018
Brander V, et al. 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. Osteoarthr Cartil. 2019;27(1):59-70. PubMed PMID: 30223023.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Brander,V, AU - Skrepnik,N, AU - Petrella,R J, AU - Jiang,G-L, AU - Accomando,B, AU - Vardanyan,A, Y1 - 2018/09/14/ PY - 2017/03/10/received PY - 2018/07/25/revised PY - 2018/08/06/accepted PY - 2018/9/18/pubmed PY - 2020/3/17/medline PY - 2018/9/18/entrez KW - Hip osteoarthritis KW - Hylan G-F 20 KW - Intra-articular injections KW - Osteoarthritis KW - Synvisc-one SP - 59 EP - 70 JF - Osteoarthritis and cartilage JO - Osteoarthr. Cartil. VL - 27 IS - 1 N2 - 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. SN - 1522-9653 UR - https://www.unboundmedicine.com/medline/citation/30223023/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1063-4584(18)31457-2 DB - PRIME DP - Unbound Medicine ER -