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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00226759

Enrollment

321

Registered

2005-09-27

Start date

2004-11-30

Completion date

2011-03-31

Last updated

2012-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Injuries

Keywords

Anterior cruciate ligament reconstruction, ACL reconstruction

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.

Interventions

DRUGOMS103HP

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

DRUGVehicle

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

15 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Improvement in knee function	30 days

Secondary

Measure	Time frame
Decreased pain	30 days
Improved range of motion	30 days
Earlier return to work	30 days

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026