Clinical Trials Directory

Trials / Completed

CompletedNCT00436969

ORTHOVISC Shoulder Osteoarthritis Study

A Comparison of Orthovisc® to Corticosteroid Injection in Shoulder Osteoarthritis: Orthovisc Randomized Clinical Trial

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
274 (actual)
Sponsor
DePuy Mitek · Industry
Sex
All
Age
25 Years – 75 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

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

Interventions

TypeNameDescription
DEVICEOrthoviscOrthovisc injection
DRUGControlCelestone (betamethasone sodium phosphate and acetate) - 2 mL

Timeline

Start date
2006-12-01
Primary completion
2010-02-01
Completion
2011-08-01
First posted
2007-02-19
Last updated
2017-03-09
Results posted
2014-04-11

Locations

13 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00436969. Inclusion in this directory is not an endorsement.