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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OMS103HP-S | Experimental | OMS103HP-S injected into vehicle irrigation solution for administration during meniscectomy surgery |
|
| Vehicle Irrigation Solution | Placebo Comparator | Vehicle Irrigation Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMS103HP-S | Drug | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
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:
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).
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| Name | Affiliation | Role |
|---|---|---|
| Steve Whitaker, MD | Omeros Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic Surgery Center | Phoenix | Arizona | 85023 | United States | ||
| Orthopedic Surgery Center |
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| Vehicle | Drug | 3 Liter bags of vehicle irrigation solution for use during meniscectomy surgery |
|
| 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 |
| Phoenix |
| Arizona |
| 85050 |
| United States |
| Orthopedic Surgery Center | Tucson | Arizona | 85712 | United States |
| Orthopedic Surgery Center | Encinitas | California | 92024 | United States |
| Orthopedic Surgery Center | Laguna Hills | California | 92653 | United States |
| Orthopedic Surgery Center | Los Angeles | California | 90045 | United States |
| Orthopedic Surgery Center | Chicago | Illinois | 60612 | United States |
| Orthopedic Surgery Center | Royal Oaks | Michigan | 48073 | United States |
| Orthopedic Surgery Center | Bloomington | Minnesota | 55431 | United States |
| Orthopedic Surgery Center | Edina | Minnesota | 55435 | United States |
| Orthopedic Surgery Center | New York | New York | 10003 | United States |
| Orthopedic Surgery Center | The Bronx | New York | 10461 | United States |
| Orthopedic Surgery Center | Durham | North Carolina | 27710 | United States |
| Orthopedic Surgery Center | Columbus | Ohio | 43221 | United States |
| Orthopedic Surgery Center | Altoona | Pennsylvania | 16602 | United States |
| Orthopedic Surgery Center | State College | Pennsylvania | 16801 | United States |
| Orthopedic Surgery Center | San Antonio | Texas | 78229 | United States |
| Orthopedic Surgery Center | Seattle | Washington | 98122 | United States |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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