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

Completed · Phase 3

Conditions studied: Anterior Cruciate Ligament Reconstruction

In brief

OMS103HP is being developed for improvement in knee function following ACL reconstruction. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee motion and earlier return to work.

Key facts

Study ID

NCT00245271

Run by

Omeros Corporation

People needed

480

Starts

2004-10-01

Expected to finish

2011-03-01

Last updated by the study team

2011-06-27

Who can join

Age: 17 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 17 - 65 years of age
• In good general health
• Undergoing arthroscopic ACL reconstruction for an ACL tear

You may not qualify if…

• Allergies to any of the individual ingredients in OMS103HP
• Has open physes in the distal femur or proximal tibia
• Undergoing bilateral knee surgery
• Subject who is considered by Investigator to be an unsuitable candidate

Where it is running

• Kerlan-Jobe Orthopaedic Clinic — Los Angeles, California, United States
• Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.) — Redwood City, California, United States
• Advanced Orthopedic and Sports Medicine Specialists — Denver, Colorado, United States
• Colorado Orthopedic Consultants, PC — Englewood, Colorado, United States
• Rush University — Chicago, Illinois, United States
• Duke University — Durham, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Ohio State University Sports Medicine — Columbus, Ohio, United States
• Temple University Orthopedics — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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