Status:
COMPLETED
Efficacy and Safety of OMS103HP in Patients Undergoing Autograft Anterior Cruciate Ligament (ACL) Reconstruction
Lead Sponsor:
Omeros Corporation
Conditions:
Knee Injuries
Eligibility:
All Genders
15-65 years
Phase:
PHASE3
Brief 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 inflamm...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT00226772
Start Date
June 1 2005
End Date
March 1 2011
Last Update
October 12 2012
Active Locations (18)
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1
CORE Orthopaedic Medical Center
Encinitas, California, United States, 92024
2
Advanced Orthopedic and Sports Medicine Specialists
Denver, Colorado, United States, 80230
3
Colorado Orthopedic Consultants, PC
Englewood, Colorado, United States, 80110
4
University of Florida
Gainesville, Florida, United States, 32611