Arthroscopic surgery MedDRA version: 13.1 Level: PT Classification code 10058471 Term: Arthroscopic surgery System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: OMS103HP-S
Product Code: OMS103HP-S
Pharmaceutical Form: Irrigation solution
INN or Proposed INN: KETOPROFEN
CAS Number: 22071-15-4
Concentration unit: mg/ml milligram(s)/millilitre
Conc
Sponsors
Omeros Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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) 2. In the opinion of the Investigator are able to comply with study-required visits and procedures 3. 18 to 75 years of age, inclusive at the time of screening 4. 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 5. Planning to undergo unilateral arthroscopic meniscectomy 6. If female and of childbearing potential (i.e., not surgically sterilized or post-menopausal for longer than one year), agree to use a medically acceptable method of birth control for the duration of her study involvement 7. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Significant arthritis in the surgical knee (Grade 3 or 4 on the Kellgren-Lawrence Grading Scale) 2. History of reactive synovial disease 3. 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 4. History of fibromyalgia 5. 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 6. Known allergies to any of the individual ingredients in OMS103HP-S, other NSAIDs, aspirin, tricyclic antidepressants, or opioid analgesics 7. Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study 8. Have a job-related claim(s) under dispute or mediation 9. History of drug or alcohol abuse 10. Treatment with an investigational drug or device within 30 days prior to the day of surgery 11. 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 12. Expected to receive a regional block for analgesia for this procedure 13. Considered by the Investigator for any reason to be an unsuitable candidate for receipt of an investigational drug 14. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms subscale through Day 30 •Safety as measured by adverse events ;Secondary Objective: 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 •Knee pain as measured by the KOOS Pain subscale through Day 30 •Knee quality of life as measured by the KOOS Quality of Life subscale through Day 30 •Knee function as measured by the KOOS Activities of Daily Living subscale through Day 30 •Passive flexion on Day 7 •Postoperative knee pain as measured by the Visual Analog Scale (VAS) during the day of surgery ;Primary end point(s): Primary Efficacy Measures The primary efficacy measure is the Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms subscale. This will be measured pre-operatively at baseline and on Days 1, 2, 3, 7, 14, and 30. The KOOS is a validated patient reported outcome with 5 subscales: Symptoms, Pain, Sports and Recreation, Activities of Daily Living, and Quality of Life. The KOOS is a recall instrument that evaluates the prior week. (The Day 1, 2, and 3 KOOS evaluations will be performed with a modified KOOS instrument evaluating the prior day because the surgical procedure is a significant traumatic event during the prior week for those assessment time points.) The Symptoms subscale is the primary efficacy measure of this study because it evaluates symptoms that are common to meniscal injuries. | — |
Countries
Czech Republic
Outcome results
None listed