RecruitingNCT05569161

To Evaluate the Safety and Clinical Radiological Outcomes in 2 Years of Embrance Model Reverse Shoulder Arthroplasty

Prospective Multicentre Longitudinal Study to Evaluate the Safety and Clinical Radiological Outcomes in the First Two Years of the Ambrace Model Reverse Shoulder Arthroplasty.


Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Enrollment

250 participants

Start Date

Mar 24, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

The use of inverted prostheses to replace shoulder joints damaged by degenerative or traumatic processes has become widespread over the past three decades. Current designs, used correctly, can restore function and improve pain in the majority of patients in whom they are implanted. The aim is to carry out a more detailed follow-up of the subjects who are implanted with this prosthetic model on a primary basis, analysing the clinical and radiological results and evaluating the presence of adverse effects of the prosthesis or short-term complications. For this purpose, subjects will be closely monitored for two years.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Patients who, after receiving information about the study design, the aims of the study, the possible risks that may arise from it and the fact that they may refuse to participate at any time, give their written consent to participate in the study.
  • Be over 18 years of age.
  • Have a shoulder joint disorder that is amenable to treatment with an Embrace reverse arthroplasty.
  • Have a CT or MRI scan performed no more than 6 months prior to surgery.
  • Translated with www.DeepL.com/Translator (free version)

Exclusion Criteria2

  • Patients who have undergone arthroplasty of any type on the ipsilateral shoulder.
  • Patients with an active infection at any site at the time of shoulder surgery.

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Locations(1)

Miguel Ángel Ruiz Ibán

Madrid, Spain

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NCT05569161