title: Novel drug OMS103HP reduces pain and improves joint motion and function for 90 days after arthroscopic meniscectomy.
abstract: OBJECTIVE
  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° or greater, 110°, and 125° was greater for the OMS103HP group. The Knee Injury and Osteoarthritis Outcome Score (KOOS) showed statistically significant differences (P ≤ .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.
  
  
  METHODS
  Level I, prospective, randomized, controlled trial.
authors.affiliation: Duke University Medical Center, Durham, North Carolina, USA.
authors.forename: William E
authors.initials: WE
authors.lastname: Garrett
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Kaeding
authors.forename: Neal S
authors.initials: NS
authors.lastname: ElAttrache
authors.forename: John W
authors.initials: JW
authors.lastname: Xerogeanes
authors.forename: Michael S
authors.initials: MS
authors.lastname: Hewitt
authors.forename: Nebojsa V
authors.initials: NV
authors.lastname: Skrepnik
authors.forename: John D
authors.initials: JD
authors.lastname: Papilion
authors.forename: John B
authors.initials: JB
authors.lastname: O'Donnell
authors.forename: David L
authors.initials: DL
authors.lastname: Fox
authors.forename: Francis
authors.initials: F
authors.lastname: Ruvuna
authors.forename: J Steven
authors.initials: JS
authors.lastname: Whitaker
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Demopulos
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000639:Amitriptyline / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001168:Arthritis / Q000209:etiology* / Q000517:prevention & control*; D001182:Arthroscopy; D003646:Debridement; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007660:Ketoprofen / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008592:Menisci, Tibial / Q000601:surgery*; D008875:Middle Aged; D010109:Oxymetazoline / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy* / Q000517:prevention & control; D011446:Prospective Studies; D016059:Range of Motion, Articular / Q000187:drug effects; D020127:Recovery of Function / Q000187:drug effects; D057566:Self Report; D000070600:Tibial Meniscus Injuries; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; C530310:OMS 103HP; D000639:Amitriptyline; D010109:Oxymetazoline; D007660:Ketoprofen