Status:
COMPLETED
Safety of OMS103HP in Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction
Lead Sponsor:
Omeros Corporation
Conditions:
Anterior Cruciate Ligament Reconstruction
Eligibility:
All Genders
17-65 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
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
- 17 - 65 years of age
- In good general health
- Undergoing arthroscopic ACL reconstruction for an ACL tear
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT00245271
Start Date
October 1 2004
End Date
March 1 2011
Last Update
June 27 2011
Active Locations (10)
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1
Kerlan-Jobe Orthopaedic Clinic
Los Angeles, California, United States, 90045
2
Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.)
Redwood City, California, United States, 94063
3
Advanced Orthopedic and Sports Medicine Specialists
Denver, Colorado, United States, 80230
4
Colorado Orthopedic Consultants, PC
Englewood, Colorado, United States, 80110