Clinical trial NCT00226759: Efficacy and Safety of OMS103HP in Patients Undergoing Allograft Anterior Cruciate Ligament (ACL) Reconstruction
Official title: Double-Blind, Multicenter Phase 3 Study Comparing the Efficacy and Safety of OMS103HP With Vehicle in Patients Undergoing Allograft ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Knee Injuries
Keywords: Anterior cruciate ligament reconstruction
ACL reconstruction
Lead sponsor: Omeros Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-27
Enrollment: 321
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Improvement in knee function
timeFrame: 30 days
Secondary outcomes:
measure: Decreased pain
timeFrame: 30 days
measure: Improved range of motion
timeFrame: 30 days
measure: Earlier return to work
timeFrame: 30 days
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: CORE Orthopaedic Medical Center
state: California
city: Redwood City
country: United States
facility: Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.)
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Englewood
country: United States
facility: Colorado Orthopedic Consultants, PC
state: Colorado
city: Steamboat Springs
country: United States
facility: American Clinical Research Services
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Southeastern Center for Clinical Trials
state: Georgia
city: Minneapolis
country: United States
facility: Minnesota Sports Medicine
state: Minnesota
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Altoona
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: State College
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Austin
country: United States
facility: Texas Orthopedics
state: Texas
city: Round Rock
country: United States
facility: Round Rock Orthopedics
state: Texas
city: San Antonio
country: United States
facility: Unlimited Research
state: Texas
city: San Marcos
country: United States
facility: Hill Country Sports Medicine
state: Texas
city: Portsmouth
country: United States
facility: Naval Medical Center - Portsmouth
state: Virginia
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
city: Ajax
country: Canada
facility: Rouge Valley Health Systems
state: Ontario
city: Windsor
country: Canada
facility: Hotel Dieu Grace Hospital
state: Ontario
Study officials:
affiliation: Omeros Corporation
name: Scott Houston
role: STUDY_DIRECTOR
References: