Safety and Efficacy of OMS103HP-S Administered in Joint Irrigation Solution to Subjects Undergoing Arthroscopic Meniscectomy

Study Overview
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Brief Summary
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The purpose of this study is to assess the effect of OMS103HP solution for Injection (OMS103HP-S) and function as measured by the Knee Osteoarthritis Outcome Survey (KOOS) Symptoms subscale through Day 30 compared with vehicle irrigation solution for knee symptoms in subjects undergoing meniscectomy.

Official Title
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A Randomized, Double-Blind, Parallel Group, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of OMS103HP-S Administered in Joint Irrigation Solution to Subjects Undergoing Arthroscopic Meniscectomy

Conditions
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Meniscal Tear

Intervention / Treatment
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* Drug: OMS103HP-S
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntarily provide written informed consent in accordance with governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements, local regulations, and Health Insurance Portability and Accountability Act (HIPAA) Authorization (or equivalent if locally applicable) In the opinion of the Investigator are able to comply with study-required visits and procedures 18 to 75 years of age, inclusive at the time of screening Have a traumatic or degenerative meniscal cartilage injury (full thickness tear) that occurred at least 14 days prior to the day of arthroscopic surgery that is demonstrated on MRI Planning to undergo unilateral arthroscopic meniscectomy If female and of childbearing potential (i.e., not surgically sterilized or post-menopausal for longer than one year), agree to use a medically accepted method of birth control for the duration of her study involvement At minimal risk from anesthesia and classified according to the American Society of Anesthesiologists Physical Status Classification as either PS-1 (a normal healthy patient) or PS-2 (a patient with mild systemic disease that results in no functional limitation) as determined by the Investigator. Exclusion Criteria: Significant arthritis in the surgical knee (Grade 3 or 4 on the Kellgren- Lawrence Grading Scale). History of reactive synovial disease History of a complex regional pain syndrome (Type I, i.e., reflex sympathetic dystrophy, or Type II, i.e., causalgia), chronic pain, attendance at a chronic pain clinic, or neurologic disorder associated with sensory deficit of the lower extremities History of fibromyalgia Expected to undergo any of the following procedures concurrent with the meniscectomy: Meniscal repair procedure Patellar tendon debridement Patellar realignment Lateral or retinacular release Excision synovectomy (minor synovectomy to improve arthroscopic visualization is allowed) Concurrent ligamentous procedure Abrasion chondroplasty involving bone Microfracture Chondral transplantation Use of more than three portals Known allergies to any of the individual ingredients in OMS103HP-S, other NSAIDs, aspirin, tricyclic antidepressants, or opioid analgesics Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study Have a job-related claim(s) under dispute or mediation History of drug or alcohol abuse Treatment with an investigational drug or device within 30 days prior to the day of surgery A clinically significant medical condition that in the opinion of the Investigator would put the subject at increased risk, impair the subject's ability to comply with the requirements of the protocol, or confound the interpretation of the data Expected to receive a regional block for analgesia for this procedure Considered by the Investigator for any reason to be an unsuitable candidate for receipt of an investigational drug The Investigator, employee of the investigative site, and/or part of the Investigator/employee's immediate families (defined as current spouse or partner, parent, natural or legally adopted child, stepchild living in the household, grandparent, or grandchild).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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-S<br>OMS103HP-S injected into vehicle irrigation solution for administration during meniscectomy surgery | Drug: OMS103HP-S<br>* Proprietary concentration and formulation of OMS103HP in solution (OMS103HP-S) for injection into each 3 liter vehicle irrigation solution bag for use during meniscectomy surgery<br>|
| Placebo Comparator: Vehicle Irrigation Solution<br>Vehicle Irrigation Solution | Drug: Vehicle<br>* 3 Liter bags of vehicle irrigation solution for use during meniscectomy surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS Symptoms Subscale | To evaluate the effect of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on knee symptoms as measured by the KOOS Symptoms subscale through Day 30. | 30 days | 
| Safety | To evaluate the safety of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on safety as measured by adverse events. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Function in Sport Active patients | To evaluate the effect of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on knee function as measured by the KOOS Sports and Recreation subscale through Day 30 in the subset of subjects who participate in sports. | 30 Days | 
| Knee Pain | To evaluate the effect of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on knee pain as measured by the KOOS Pain subscale through Day 30. | 30 days | 
| Quality of Life | To evaluate the effect of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on knee quality of life as measured by the KOOS Quality of Life subscale through Day 30. | 30 days | 
| Knee Function | To evaluate the effect of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on knee function as measured by the KOOS Activities of Daily Living subscale through Day 30. | 30 days | 
| Postoperative Knee Pain | To evaluate the effect of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on postoperative knee pain as measured by the Visual Analog Scale during the day of surgery. | Day of Surgery (day 1) | 
| Passive Flexion | To evaluate the effect of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on Passive flexion on Day 7. | 7 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meniscectomy, Knee Pain, Postoperative Pain