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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
344
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
3 Liter bags of vehicle irrigation solution for use during meniscectomy surgery
Orthopedic Surgery Center
Phoenix, Arizona, United States
Orthopedic Surgery Center
Phoenix, Arizona, United States
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.
Time frame: 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.
Time frame: 90 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 7 Days