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

Phase 3

Completed

• Conditions: Knee Injuries
• Interventions: Drug: OMS103HP; Drug: Vehicle

• Registration Number: NCT00226759
• 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. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee range of motion and earlier return to work.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-26
• Study First Submitted QC: 2005-09-26
• Study First Posted: 2005-09-27
• Primary Completion: 2010-09
• Study Completion: 2011-03
• Status Verified: 2012-10
• Disposition First Submitted: 2012-10-10
• Disposition First Submitted QC: 2012-10-10
• Last Update Submitted: 2012-10-10
• Disposition First Posted: 2012-10-12
• Last Update Posted: 2012-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321

Inclusion Criteria

• 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 an allograft (patellar tendon bone, Achilles tendon, tibialis tendon, or hamstring)
• Able to participate in the study rehabilitation protocol
• and other inclusion criteria

Exclusion Criteria

• No allergies to any of the individual ingredients in OMS103HP
• No medications with the same activities as that of the active ingredients in OMS103HP for defined time intervals prior to and after surgery
• No 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
Earlier return to work	30 days
Decreased pain	30 days
Improved range of motion	30 days

Trial Locations

Locations (19)

CORE Orthopaedic Medical Center; 🇺🇸 Encinitas, California, United States

Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.); 🇺🇸 Redwood City, California, United States

Stanford University; 🇺🇸 Stanford, California, United States

Colorado Orthopedic Consultants, PC; 🇺🇸 Englewood, Colorado, United States

American Clinical Research Services; 🇺🇸 Steamboat Springs, Colorado, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Southeastern Center for Clinical Trials; 🇺🇸 Atlanta, Georgia, United States

Minnesota Sports Medicine; 🇺🇸 Minneapolis, Minnesota, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

University Orthopedics Center; 🇺🇸 State College, Pennsylvania, United States

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