NCT00226759

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2004

Longer than P75 for phase_3

Geographic Reach
2 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

October 12, 2012

Status Verified

October 1, 2012

Enrollment Period

5.8 years

First QC Date

September 26, 2005

Last Update Submit

October 10, 2012

Conditions

Knee Injuries

Keywords

Anterior cruciate ligament reconstructionACL reconstruction

Outcome Measures

Primary Outcomes (1)

  • Improvement in knee function

    30 days

Secondary Outcomes (3)

  • Decreased pain

    30 days

  • Improved range of motion

    30 days

  • Earlier return to work

    30 days

Study Arms (2)

OMS103HP irrigation solution

EXPERIMENTAL

Drug

Drug: OMS103HP

vehicle irrigation solution

PLACEBO COMPARATOR

Vehicle

Drug: Vehicle

Interventions

OMS103HPDRUG

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

OMS103HP irrigation solution
VehicleDRUG

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

vehicle irrigation solution

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

CORE Orthopaedic Medical Center

Encinitas, California, 92024, United States

Location

Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.)

Redwood City, California, 94063, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Colorado Orthopedic Consultants, PC

Englewood, Colorado, 80110, United States

Location

American Clinical Research Services

Steamboat Springs, Colorado, 80487, United States

Location

University of Florida

Gainesville, Florida, 32607, United States

Location

Southeastern Center for Clinical Trials

Atlanta, Georgia, 30350, United States

Location

Minnesota Sports Medicine

Minneapolis, Minnesota, 55454, United States

Location

Ohio State University

Columbus, Ohio, 43221, United States

Location

University Orthopedics Center

Altoona, Pennsylvania, 16602, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15203, United States

Location

University Orthopedics Center

State College, Pennsylvania, 16801, United States

Location

Texas Orthopedics

Austin, Texas, 78759, United States

Location

Round Rock Orthopedics

Round Rock, Texas, 78681, United States

Location

Unlimited Research

San Antonio, Texas, 78217, United States

Location

Hill Country Sports Medicine

San Marcos, Texas, 78666, United States

Location

Naval Medical Center - Portsmouth

Portsmouth, Virginia, 23708, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Rouge Valley Health Systems

Ajax, Ontario, L1S 2J5, Canada

Location

Hotel Dieu Grace Hospital

Windsor, Ontario, N9A 1E1, Canada

Location

MeSH Terms

Conditions

Knee Injuries

Interventions

OMS 103HP

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Scott Houston

    Omeros Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2005

First Posted

September 27, 2005

Study Start

November 1, 2004

Primary Completion

September 1, 2010

Study Completion

March 1, 2011

Last Updated

October 12, 2012

Record last verified: 2012-10

Locations

US(18)CA(2)