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

Completed · Phase 3

Conditions studied: Knee Injuries

In brief

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. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee range of motion and earlier return to work.

Key facts

Study ID

NCT00226759

Run by

Omeros Corporation

People needed

321

Starts

2004-11-01

Expected to finish

2011-03-01

Last updated by the study team

2012-10-12

Who can join

Age: 15 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 15 - 65 years of age
• In good general health with an ACL tear that occurred from 2 weeks to 18 months prior to the day of arthroscopic surgery
• Undergoing primary unilateral ACL reconstruction using an allograft (patellar tendon bone, Achilles tendon, tibialis tendon, or hamstring)
• Able to participate in the study rehabilitation protocol
• and other inclusion criteria

You may not qualify if…

• No allergies to any of the individual ingredients in OMS103HP
• No medications with the same activities as that of the active ingredients in OMS103HP for defined time intervals prior to and after surgery
• No associated knee injuries likely to interfere with evaluation of the study drug
• and other exclusion criteria

Where it is running

• CORE Orthopaedic Medical Center — Encinitas, California, United States
• Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.) — Redwood City, California, United States
• Stanford University — Stanford, California, United States
• Colorado Orthopedic Consultants, PC — Englewood, Colorado, United States
• American Clinical Research Services — Steamboat Springs, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• Southeastern Center for Clinical Trials — Atlanta, Georgia, United States
• Minnesota Sports Medicine — Minneapolis, Minnesota, United States
• Ohio State University — Columbus, Ohio, United States
• University Orthopedics Center — Altoona, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• University Orthopedics Center — State College, Pennsylvania, United States
• Texas Orthopedics — Austin, Texas, United States
• Round Rock Orthopedics — Round Rock, Texas, United States
• Unlimited Research — San Antonio, Texas, United States
• Hill Country Sports Medicine — San Marcos, Texas, United States
• Naval Medical Center - Portsmouth — Portsmouth, Virginia, United States
• Madigan Army Medical Center — Tacoma, Washington, United States
• Rouge Valley Health Systems — Ajax, Ontario, Canada
• Hotel Dieu Grace Hospital — Windsor, Ontario, Canada

Full record on ClinicalTrials.gov

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