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

NCT00226772 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2012-10-12

No results posted yet for this study

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.

Conditions

  • Knee Injuries

Interventions

DRUG

OMS103HP

Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours

DRUG

Vehicle

Maximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours

Sponsors & Collaborators

  • Omeros Corporation

    lead INDUSTRY

Principal Investigators

  • Scott Houston · Omeros Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2010-09-30
Completion
2011-03-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00226772 on ClinicalTrials.gov