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

Study Overview
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Brief Summary
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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.

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

Conditions
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Knee Injuries

Intervention / Treatment
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* Drug: OMS103HP
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OMS103HP irrigation solution<br>Drug | Drug: OMS103HP<br>* Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours<br>|
| Placebo Comparator: vehicle irrigation solution<br>Vehicle | Drug: Vehicle<br>* Maximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in knee function |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased pain |  | 30 days | 
| Improved range of motion |  | 30 days | 
| Earlier return to work |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL reconstruction, Anterior cruciate ligament reconstruction