Efficacy and Safety of OMS103HP in Patients Undergoing Autograft Anterior Cruciate Ligament (ACL) Reconstruction
- Conditions
- Knee Injuries
- Interventions
- Drug: OMS103HPDrug: Vehicle
- Registration Number
- NCT00226772
- Lead Sponsor
- Omeros Corporation
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 326
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OMS103HP irrigation solution OMS103HP Drug vehicle irrigation solution Vehicle Vehicle
- Primary Outcome Measures
Name Time Method Improvement in knee function 30 days
- Secondary Outcome Measures
Name Time Method Decreased pain 30 days Improved range of motion 30 days Earlier return to work 30 days
Trial Locations
- Locations (18)
Colorado Orthopedic Consultants, PC
๐บ๐ธEnglewood, Colorado, United States
William Beaumont Hospital
๐บ๐ธRoyal Oak, Michigan, United States
University Orthopedics Center
๐บ๐ธState College, Pennsylvania, United States
Round Rock Orthopedics
๐บ๐ธRound Rock, Texas, United States
University Orthopedics Center - Altoona
๐บ๐ธAltoona, Pennsylvania, United States
Basin Orthopedic Surgical Specialists
๐บ๐ธOdessa, Texas, United States
Advanced Orthopedic and Sports Medicine Specialists
๐บ๐ธDenver, Colorado, United States
CORE Orthopaedic Medical Center
๐บ๐ธEncinitas, California, United States
Rouge Valley Health Systems
๐จ๐ฆAjax, Ontario, Canada
Texas Orthopedics
๐บ๐ธAustin, Texas, United States
Minnesota Sports Medicine
๐บ๐ธMinneapolis, Minnesota, United States
Lifemark Health Research Group
๐จ๐ฆCalgary, Alberta, Canada
Fowler Kennedy Sport Medicine Clinic
๐จ๐ฆLondon, Ontario, Canada
Madigan Army Medical Center
๐บ๐ธTacoma, Washington, United States
Hill Country Sports Medicine
๐บ๐ธSan Marcos, Texas, United States
Naval Medical Center - Portsmouth
๐บ๐ธPortsmouth, Virginia, United States
Unlimited Research
๐บ๐ธSan Antonio, Texas, United States
University of Florida
๐บ๐ธGainesville, Florida, United States