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

ClinicalTrials.gov ID: NCT00226772

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Official title

Double-Blind, Multicenter Phase 3 Study Comparing the Efficacy and Safety of OMS103HP With Vehicle in Patients Undergoing Autograft ACL Reconstruction

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT00226772
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Omeros Corporation; Industry
Enrollment: 326 participants

Conditions and interventions

Conditions

Knee Injuries

Interventions

OMS103HP Drug
Vehicle Drug

Drug

Eligibility (public fields only)

Age range: 15 Years to 65 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 2005 (Type not available)
Primary completion: Sep 2010 (Actual)
Completion: Mar 2011 (Actual)
Last update posted: Oct 12, 2012

2005 – 2011

United States locations

U.S. sites: 15
U.S. states: 9
U.S. cities: 15

Facility	City	State	ZIP	Site status
CORE Orthopaedic Medical Center	Encinitas	California	92024	—
Advanced Orthopedic and Sports Medicine Specialists	Denver	Colorado	80230	—
Colorado Orthopedic Consultants, PC	Englewood	Colorado	80110	—
University of Florida	Gainesville	Florida	32611	—
William Beaumont Hospital	Royal Oak	Michigan	48073	—
Minnesota Sports Medicine	Minneapolis	Minnesota	55454	—
University Orthopedics Center - Altoona	Altoona	Pennsylvania	16602	—
University Orthopedics Center	State College	Pennsylvania	16801	—
Texas Orthopedics	Austin	Texas	78759	—
Basin Orthopedic Surgical Specialists	Odessa	Texas	79761	—
Round Rock Orthopedics	Round Rock	Texas	78681	—
Unlimited Research	San Antonio	Texas	78217	—
Hill Country Sports Medicine	San Marcos	Texas	78666	—
Naval Medical Center - Portsmouth	Portsmouth	Virginia	23708	—
Madigan Army Medical Center	Tacoma	Washington	98431	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00226772, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 12, 2012 · Synced Nov 15, 2026