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NCT02305966 Clinical Trial

Evaluation of Implant Fixation in Reverse Total Shoulder Arthroplasty

Arthritis Clinical Trial

Official title:
Evaluation of Implant Fixation in Reverse Total Shoulder Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02305966
Other study ID # 7519
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received October 30, 2014
Last updated March 22, 2017
Start date August 1, 2017
Est. completion date November 2019

Study information
Verified date March 2017
Source Lawson Health Research Institute
Contact Kate Kelly, M.Sc,MPH/Gero
Phone 519-646-6100
Email Kate.Kelly@sjhc.london.on.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date November 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 50 Years to 85 Years
Eligibility Inclusion Criteria:

- will be any patient with cuff tear arthropathy requiring reverse shoulder arthroplasty.

Exclusion Criteria:

- will be any patient with a previous RTSA or TSA (i.e. no revision surgery) or anyone unable to return for RSA imaging (e.g. living >100 km outside of London).

Study Design

Related Conditions & MeSH terms

Intervention

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,

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Lawson Health Research Institute

Outcome
Type Measure Description Time frame Safety issue
Primary migration between cemented and press-fit RTSA humeral components detected by Radiostereometric analysis 24 months
Secondary difference in component migration between conventional and lateralized glenoid components detected by Radiostereometric analysis 24 months
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