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ORTHOVISC Shoulder Osteoarthritis Study

NCT ID: NCT00436969

Last Updated: 2017-03-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2011-08-31

Brief Summary

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A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.

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Detailed Description

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This multicenter, prospective double-blinded, randomized trial will study two treatment groups. Subjects will be randomized to receive either Orthovisc or corticosteroids/anesthetic injection into the shoulder in a 2:1 schema. The trial will assess safety and efficacy of pain relief in the osteoarthritic shoulder.

Conditions

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Glenohumeral Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

Subjects randomized to the control arm injection of prescribed anesthetic and corticosteroid, shall receive an equivalent volume (8 mL's).

Group Type ACTIVE_COMPARATOR

Control

Intervention Type DRUG

Celestone (betamethasone sodium phosphate and acetate) - 2 mL

Investigational

Subjects randomized to the active treatment in this study will receive a one-time dose of 8 mL's of Orthovisc derived from non-animal source bacterial fermentation, S. Equi.

Group Type EXPERIMENTAL

Orthovisc

Intervention Type DEVICE

Orthovisc injection

Interventions

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Orthovisc

Orthovisc injection

Intervention Type DEVICE

Control

Celestone (betamethasone sodium phosphate and acetate) - 2 mL

Intervention Type DRUG

Other Intervention Names

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Hyaluronic acid Corticosteroid

Eligibility Criteria

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Inclusion Criteria

* A candidate for unilateral treatment of osteoarthritis of the shoulder
* Have failed conservative treatment

Exclusion Criteria

* Presence of full thickness Rotator Cuff tear and/or significantly compromised rotator cuff function
* No active instability or acute dislocation episodes within the previous 12 months
* Known allergy to hyaluronate preparations
* Pregnant or breast feeding
* Is receiving prescription pain medication for conditions unrelated to the index shoulder condition
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DePuy Mitek

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan B. McGlohorn

Role: STUDY_DIRECTOR

DePuy Synthes Mitek and Biomaterials

Locations

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CORE Orthopedics

Encinitas, California, United States

Site Status

Sierra Pacific Orthopaedic Center Medical Group

Fresno, California, United States

Site Status

UHZ Sports Medicine

Coral Gables, Florida, United States

Site Status

Andrews Research Institute

Gulf Breeze, Florida, United States

Site Status

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

University of Massachusetts Merdical School - Worcester

Worcester, Massachusetts, United States

Site Status

Shores Rheumatology

Saint Clair Shores, Michigan, United States

Site Status

Insall Scott Kelly Institute

New York, New York, United States

Site Status

Tulsa Bone and Joint

Tulsa, Oklahoma, United States

Site Status

University Orthopedics Center

State College, Pennsylvania, United States

Site Status

The Methodist

Houston, Texas, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Madigan Army Medical Center

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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06-OV-01

Identifier Type: -

Identifier Source: org_study_id

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