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

Omeros

Status and phase

Completed

Phase 3

Conditions

Knee Injuries

Treatments

Drug: Vehicle

Drug: OMS103HP

Study type

Interventional

Funder types

Industry

Identifiers

NCT00226772

C03512

Details and patient eligibility

About

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.

Enrollment

326 patients

Sex

All

Ages

15 to 65 years old

Volunteers

No 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 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