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A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears

Rotator Cuff Syndrome Clinical Trial

Official title:
A Prospective, Single Blinded, Multi-center, Randomized, Controlled, Pivotal Study to Assess the Safety and Effectiveness of the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears

Clinical Trial Summary

A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical partial repair of full thickness Massive Rotator Cuff Tear (MRCT).

Clinical Trial Description

This is a non-inferiority, prospective, single blinded, multi-center, randomized, controlled, pivotal study evaluating the safety and effectiveness of the InSpace™ device as a primary surgical treatment for full thickness MRCT in comparison to Partial Repair of a full thickness MRCT performed during an arthroscopic procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02493660
Study type Interventional
Source OrthoSpace Ltd.
Contact
Status Completed
Phase N/A
Start date June 26, 2015
Completion date March 17, 2020
View Details
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