RESUMO
PURPOSE: OMS103HP, an investigational drug product containing ketoprofen, amitriptyline, and oxymetazoline, is added to arthroscopic irrigation solution. OMS103HP was evaluated in patients undergoing arthroscopic anterior cruciate ligament reconstruction to assess the drug's safety and ability to improve postoperative knee function and motion, reduce postoperative pain, and allow earlier return to work. METHODS: This was a prospective, double-blind, vehicle-controlled, parallel-group, randomized study. Allograft anterior cruciate ligament reconstruction patients in both treatment and vehicle control groups were monitored for safety and efficacy (e.g., measurements of knee function and motion, pain, and return to work) over a 30-day postoperative period. The efficacy endpoints of primary interest were assessed by use of both responder and time-to-event analyses. RESULTS: There were statistically significant differences (P < or = .05) between the OMS103HP and vehicle control groups in the endpoints of knee function (knee function composite and straight-leg raise component of knee function composite), range of motion (median number of days to maximum passive flexion of 90 degrees or greater without pain and time to discontinuation of continuous passive motion), quadriceps and hamstring muscle strength, successful pain management, and return to work. The overall incidences of adverse events and abnormal clinical laboratory values for both OMS103HP- and vehicle-treated subjects were similar, and none was attributed to OMS103HP. CONCLUSIONS: The clinical benefits of OMS103HP in this study were reduced postoperative pain; improved postoperative knee motion, quadriceps and hamstring muscle strength, and knee function; and earlier return to work as measured by surgeons, nurses, and physical therapists across repeated clinic visits and rehabilitation sessions and recorded by patients in daily diaries. The drug was well tolerated.
