NCT01406561

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
344

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 26, 2018

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

July 28, 2011

Last Update Submit

October 24, 2018

Conditions

Meniscal Tear

Keywords

MeniscectomyKnee PainPostoperative Pain

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Knee Function in Sport Active patients

    30 Days

  • Knee Pain

    30 days

  • Quality of Life

    30 days

  • Knee Function

    30 days

  • Postoperative Knee Pain

    Day of Surgery (day 1)

  • +1 more secondary outcomes

Study Arms (2)

OMS103HP-S

EXPERIMENTAL

OMS103HP-S injected into vehicle irrigation solution for administration during meniscectomy surgery

Drug: OMS103HP-S

Vehicle Irrigation Solution

PLACEBO COMPARATOR

Vehicle Irrigation Solution

Drug: Vehicle

Interventions

OMS103HP-SDRUG

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

OMS103HP-S
VehicleDRUG

3 Liter bags of vehicle irrigation solution for use during meniscectomy surgery

Vehicle Irrigation Solution

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Orthopedic Surgery Center

Phoenix, Arizona, 85023, United States

Location

Orthopedic Surgery Center

Phoenix, Arizona, 85050, United States

Location

Orthopedic Surgery Center

Tucson, Arizona, 85712, United States

Location

Orthopedic Surgery Center

Encinitas, California, 92024, United States

Location

Orthopedic Surgery Center

Laguna Hills, California, 92653, United States

Location

Orthopedic Surgery Center

Los Angeles, California, 90045, United States

Location

Orthopedic Surgery Center

Chicago, Illinois, 60612, United States

Location

Orthopedic Surgery Center

Royal Oaks, Michigan, 48073, United States

Location

Orthopedic Surgery Center

Bloomington, Minnesota, 55431, United States

Location

Orthopedic Surgery Center

Edina, Minnesota, 55435, United States

Location

Orthopedic Surgery Center

New York, New York, 10003, United States

Location

Orthopedic Surgery Center

The Bronx, New York, 10461, United States

Location

Orthopedic Surgery Center

Durham, North Carolina, 27710, United States

Location

Orthopedic Surgery Center

Columbus, Ohio, 43221, United States

Location

Orthopedic Surgery Center

Altoona, Pennsylvania, 16602, United States

Location

Orthopedic Surgery Center

State College, Pennsylvania, 16801, United States

Location

Orthopedic Surgery Center

San Antonio, Texas, 78229, United States

Location

Orthopedic Surgery Center

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Steve Whitaker, MD

    Omeros Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2011

First Posted

August 1, 2011

Study Start

August 1, 2011

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

October 26, 2018

Record last verified: 2018-10

Locations

US(18)