NCT00226772

Efficacy and Safety of OMS103HP in Patients Undergoing Autograft Anterior Cruciate Ligament (ACL) Reconstruction

Double-Blind, Multicenter Phase 3 Study Comparing the Efficacy and Safety of OMS103HP With Vehicle in Patients Undergoing Autograft ACL Reconstruction

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: Omeros Corporation · Industry
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic surgeons replace the torn ligament during ACL reconstruction surgery. Surgical trauma initiates an acute inflammatory response, including swelling and pain, that leads to restricted joint motion and loss of function. OMS103HP was designed to deliver targeted therapeutic agents directly to the surgical site during the arthroscopic procedure to inhibit inflammation and pain before they can begin. The purpose of this study is to assess the effectiveness and safety of OMS103HP in improving knee function following ACL reconstruction using a hamstring autograft. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee range of motion, and earlier return to work.

Conditions

• Knee Injuries

Interventions

Type	Name	Description
DRUG	OMS103HP	Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours
DRUG	Vehicle	Maximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours

Timeline

• Start date: 2005-06-01
• Primary completion: 2010-09-01
• Completion: 2011-03-01
• First posted: 2005-09-27
• Last updated: 2012-10-12

Locations

18 sites across 2 countries: United States, Canada