Efficacy and Safety of OMS103HP in Patients Undergoing Autograft 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 using a hamstring autograft. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee range of motion, and earlier return to work.

Key facts

Study ID

NCT00226772

Run by

Omeros Corporation

People needed

326

Starts

2005-06-01

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 a medial hamstring (semitendinosus and gracilis) autograft
• Able to participate in the study rehabilitation protocol
• and other inclusion criteria

You may not qualify if…

• Allergies to any of the individual ingredients in OMS103HP
• Taking medications with the same activities as that of the active ingredients in OMS103HP for defined time intervals prior to and after surgery
• 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
• Advanced Orthopedic and Sports Medicine Specialists — Denver, Colorado, United States
• Colorado Orthopedic Consultants, PC — Englewood, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Minnesota Sports Medicine — Minneapolis, Minnesota, United States
• University Orthopedics Center - Altoona — Altoona, Pennsylvania, United States
• University Orthopedics Center — State College, Pennsylvania, United States
• Texas Orthopedics — Austin, Texas, United States
• Basin Orthopedic Surgical Specialists — Odessa, 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
• Lifemark Health Research Group — Calgary, Alberta, Canada
• Rouge Valley Health Systems — Ajax, Ontario, Canada
• Fowler Kennedy Sport Medicine Clinic — London, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.