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OpenTrials
Completed

NCT Number: NCT03730597

Glenosphere Size and Scapular Notch in RSA, Prospective Randomized Study

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reverse Shoulder Arthroplasty

Device

prosthesis implantation

Other names: Delta X-tend

Primary outcomes

  1. scapular notch development

    Time frame: two years

    X-ray assessment of scapular notch development

Sponsors and collaborators

Lead sponsor

Hospital del Mar

Other

Registry information

Official study title

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

Acronym: GSSNRSA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 5, 2018
Registry last updated
Mar 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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