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Completed

NCT Number: NCT00226772

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

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.

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Key information

Conditions

Knee Injuries Leg Injuries Wounds and Injuries

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lifemark Health Research Group, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 a medial hamstring (semitendinosus and gracilis) autograft
  • Able to participate in the study rehabilitation protocol
  • and other inclusion criteria

Exclusion criteria

  • Allergies to any of the individual ingredients in OMS103HP
  • 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
  • and other exclusion criteria

Treatment and study plan

OMS103HP

Drug

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

Vehicle

Drug

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

Primary outcomes

  1. Improvement in knee function

    Time frame: 30 days

Secondary outcomes

  1. Decreased pain

    Time frame: 30 days

  2. Improved range of motion

    Time frame: 30 days

  3. Earlier return to work

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Omeros Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
Study completion
2011
First posted
Sep 27, 2005
Registry last updated
Oct 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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