Efficacy and Safety of OMS103HP in Patients Undergoing Allograft Anterior Cruciate Ligament (ACL) Reconstruction
Public ClinicalTrials.gov record NCT00226759. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Double-Blind, Multicenter Phase 3 Study Comparing the Efficacy and Safety of OMS103HP With Vehicle in Patients Undergoing Allograft 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. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee range of motion and earlier return to work.
Study identification
- NCT ID
- NCT00226759
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 321 participants
Conditions and interventions
Conditions
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
- Nov 2004 (Type not available)
- Primary completion
- Sep 2010 (Actual)
- Completion
- Mar 2011 (Actual)
- Last update posted
- Oct 12, 2012
2004 – 2011
United States locations
- U.S. sites
- 18
- U.S. states
- 10
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| CORE Orthopaedic Medical Center | Encinitas | California | 92024 | — |
| Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.) | Redwood City | California | 94063 | — |
| Stanford University | Stanford | California | 94305 | — |
| Colorado Orthopedic Consultants, PC | Englewood | Colorado | 80110 | — |
| American Clinical Research Services | Steamboat Springs | Colorado | 80487 | — |
| University of Florida | Gainesville | Florida | 32607 | — |
| Southeastern Center for Clinical Trials | Atlanta | Georgia | 30350 | — |
| Minnesota Sports Medicine | Minneapolis | Minnesota | 55454 | — |
| Ohio State University | Columbus | Ohio | 43221 | — |
| University Orthopedics Center | Altoona | Pennsylvania | 16602 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15203 | — |
| University Orthopedics Center | State College | Pennsylvania | 16801 | — |
| Texas Orthopedics | Austin | Texas | 78759 | — |
| 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 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00226759, 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 Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00226759 live on ClinicalTrials.gov.