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Clinical Trial Summary

Three-arm, parallel, double-blind, masked observer, randomized, PB-Saline controlled clinical trial. In order to avoid problems in the interpretation of the final results due to disparate enrollment from various centers, the number of patients enrolled per site will be the same per site. Study patients will be randomized to receive either 20 mg sodium hyaluronate, 3 i.a. sodium hyaluronate injections, followed by 2 PBSaline mock i.a. injections or 5 i.a. PB-Saline control injections. One investigator will administer the injection and the joint assessor will be blinded to the study. The anterior or posterior approach for the shoulder injection will be used.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00377624
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date January 2002
Completion date September 2004

See also
  Status Clinical Trial Phase
Recruiting NCT06154694 - Glenohumeral Joint Contract Patterns in Osteoarthritic Glenoids
Recruiting NCT03921944 - Evaluation of Structural and Functional Integrity of the Rotator Cuff After Total Shoulder Arthroplasty N/A