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

Meniscal Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406561
• Other study ID #: OMS103-MEN-002
• Status: Completed
• Phase: Phase 3
• Start date: August 2011
• Est. completion date: December 2012

Study information

• Verified date: October 2018
• Source: Omeros Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 accepted 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.

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).

Related Conditions & MeSH terms

• Meniscal Tear

Intervention

Drug:
• OMS103HP-S
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
• Vehicle
3 Liter bags of vehicle irrigation solution for use during meniscectomy surgery

Locations

Country	Name	City	State
United States	Orthopedic Surgery Center	Altoona	Pennsylvania
United States	Orthopedic Surgery Center	Bloomington	Minnesota
United States	Orthopedic Surgery Center	Bronx	New York
United States	Orthopedic Surgery Center	Chicago	Illinois
United States	Orthopedic Surgery Center	Columbus	Ohio
United States	Orthopedic Surgery Center	Durham	North Carolina
United States	Orthopedic Surgery Center	Edina	Minnesota
United States	Orthopedic Surgery Center	Encinitas	California
United States	Orthopedic Surgery Center	Laguna Hills	California
United States	Orthopedic Surgery Center	Los Angeles	California
United States	Orthopedic Surgery Center	New York	New York
United States	Orthopedic Surgery Center	Phoenix	Arizona
United States	Orthopedic Surgery Center	Phoenix	Arizona
United States	Orthopedic Surgery Center	Royal Oaks	Michigan
United States	Orthopedic Surgery Center	San Antonio	Texas
United States	Orthopedic Surgery Center	Seattle	Washington
United States	Orthopedic Surgery Center	State College	Pennsylvania
United States	Orthopedic Surgery Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Omeros Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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