Efficacy and Safety of OMS103HP in Patients Undergoing Autograft Anterior Cruciate Ligament (ACL) Reconstruction
NCT ID: NCT00226772
Last Updated: 2012-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
326 participants
INTERVENTIONAL
2005-06-30
2011-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
OMS103HP irrigation solution
Drug
OMS103HP
Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours
vehicle irrigation solution
Vehicle
Vehicle
Maximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
OMS103HP
Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours
Vehicle
Maximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
15 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Omeros Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Scott Houston
Role: STUDY_DIRECTOR
Omeros Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C03512
Identifier Type: -
Identifier Source: org_study_id