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NCT03730597 Clinical Trial

Glenosphere Size and Scapular Notch in RSA, Prospective Randomized Study

Total Shoulder Arthroplasty Clinical Trial

— GSSNRSA  

Official title:
Influenze of Glenosphere Size in Scapular Notch Development. Randomized Study Comparing 42 to 38 ECC

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03730597
Other study ID # Torrens.00
Secondary ID CTorrens
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2014
Est. completion date September 9, 2016

Study information
Verified date October 2018
Source Hospital del Mar
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Scapular notch can be reduced by using bigger glenospheres but in some patients it cannot be implanted because of small size. If small size of glenosphere is used then scapular notch may increase. To improve that situation, eccentricity has been added to some glenospheres to increase glenoid overhanging. The objective is to assess if eccentricity can avoid scapular notch as effectively as bigger glenospheres.

Recruitment information / eligibility
Status Completed
Enrollment 95
Est. completion date September 9, 2016
Est. primary completion date September 9, 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients undergoing reverse shoulder prosthesis because of rotator cuff disordes andacute fractures

Exclusion Criteria:

- patients with previous surgery

- patients with deltoid deficiency

- patients with acute infection

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• reverse shoulder arthroplasty
prosthesis implantation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospital del Mar

Outcome
Type Measure Description Time frame Safety issue
Primary scapular notch development X-ray assessment of scapular notch development two years
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