- 作者：William E. Garrett ; M.D. ; Ph.D.a ; Christopher C. Kaeding ; M.D.b ; Neal S. ElAttrache ; M.D.c ; John W. Xerogeanes ; M.D.d ; Michael S. Hewitt ; M.D.e ; Nebojsa V. Skrepnik ; M.D. ; Ph.D.f ; John D. Papilion ; M.D.g ; John B. O'Donnell ; M.D.h ; David L. Fox ; M.D.i ; Francis Ruvuna ; Ph.D.j ; J. Steven Whitaker ; M.D. ; J.D.k ; swhitaker@omeros.com ; Gregory A. Demopulos ; M.D.k
- 刊名：Arthroscopy: The Journal of Arthroscopic & Related Surgery
- 出版年：2011
- 出版时间：August, 2011
- 年：2011
- 卷：27
- 期：8
- 页码：1060-1070
- 全文大小：1007 K
Purpose
This phase 2 study compared OMS103HP (Omeros, Seattle, WA) with control (lactated Ringer's) irrigation solution in patients undergoing arthroscopic partial meniscectomy.Methods
This was a prospective, multicenter, double-blind, randomized, vehicle-controlled, parallel-group study. Safety and postoperative pain, range of motion, and self-reported function were evaluated for 90 days. Statistical results were based on univariate analysis of variance and repeated-measures analyses.
Results
Mean visual analog scale (VAS) pain scores within 24 hours after discharge from the recovery room showed more pain in the control group beginning at 2 hours and peaking at 8 hours. Univariate analysis of variance of mean VAS scores over the 24-hour period did not meet statistical significance. Repeated-measures analysis yielded a statistically significant difference (P = .004) for time-by-treatment interaction, showing a clear drug benefit over time based on VAS scores. There were statistically significant differences at day 7 between the groups in passive flexion without pain (P = .022). The proportion of patients achieving flexion of 95¡ã or greater, 110¡ã, and 125¡ã was greater for the OMS103HP group. The Knee Injury and Osteoarthritis Outcome Score (KOOS) showed statistically significant differences (P ¡Ü .05) between the OMS103HP and control groups for 4 of 5 outcomes (symptoms, pain, sport and recreation, and knee-based quality of life but not activities of daily living). All scores showed a treatment effect through day 90. The overall incidence of adverse events and abnormal laboratory values for the OMS103HP and control groups was similar. Serious adverse events occurred in 1 control patient.
Conclusions
In this study of patients with meniscal tears who underwent simple debridement, the use of OMS103HP resulted in reduced acute postoperative pain (measured by VAS over the first 24 hours postoperatively), reduced pain during recovery (measured by the KOOS pain subscale, which measures both background levels of pain and exacerbations caused by movements or activities), improved postoperative knee motion, and improved functional outcomes as assessed with the KOOS Knee Survey. Clinical benefits of OMS103HP were consistent and sustained throughout 90 days of postoperative follow-up.
Level of Evidence
Level I, prospective, randomized, controlled trial.