NCT02305966

Evaluation of Implant Fixation in Reverse Total Shoulder Arthroplasty

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Reverse total shoulder replacement surgery (RTSA) is performed for individuals with advanced arthritis of the shoulder who also have tears in their rotator cuff muscles. A metal hemisphere is placed in the shoulder blade, and a plastic cup on a stem is placed in the upper arm. This orientation is opposite to the normal anatomy, giving rise to the term "reverse" shoulder replacement. While RTSA has a good clinical track record, no studies have examined how well fixed the implanted components are within patients.

Conditions

• Arthritis

Interventions

Type	Name	Description
PROCEDURE	surgery	All patients will receive a Delta XTEND reverse shoulder implant
DEVICE	0.8 mm diameter Tantalum marker beads	At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant,

Timeline

• Start date: 2017-08-01
• Primary completion: 2018-12-01
• Completion: 2019-11-01
• First posted: 2014-12-03
• Last updated: 2017-03-24