Double-Blind, Multicenter Phase 3 Study Comparing the Efficacy and Safety of OMS103HP With Vehicle in Patients Undergoing Allograft ACL Reconstruction
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Omeros Corporation
- Enrollment
- 321
- Locations
- 19
- Primary Endpoint
- Improvement in knee function
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
OMS103HP irrigation solution
Drug
Intervention: OMS103HP (Drug)
vehicle irrigation solution
Vehicle
Intervention: Vehicle (Drug)
Outcomes
Primary Outcomes
Improvement in knee function
Time Frame: 30 days
Secondary Outcomes
- Earlier return to work(30 days)
- Decreased pain(30 days)
- Improved range of motion(30 days)