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NCT Number: NCT05569161

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Miguel Ángel Ruiz Ibán

Madrid, 28034, Spain

Location status: Recruiting

Location contact

Miguel Ángel RI Ruiz Iban, DR

CONTACT

[email protected]

913368208

About this study

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.

However, there are complications associated with shoulder arthroplasty surgery, such as wear of the prosthetic components, infection, allergy to the prosthetic components, or failure to restore full shoulder function. The occurrence of these complications is affected by multiple factors dependent on the subject, the surgeon and/or the implant used.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. To assess the safety and the clinical and radiological outcome of Embrace primary reverse shoulder prostheses.

    Time frame: 24 months

    survival at 2-year follow-up with computerized tomografhic

Secondary outcomes

  1. security

    Time frame: 24 months

    presence of possible adverse effects or complications, implant-related or not, including infection, mechanical complications of the implant, dislocation, fracture, loosening, readmission, reoperation or fracture.

  2. efficiency

    Time frame: 24 months

    To evaluate the effect of the Embrace Reverse Embrace arthroplasty on postoperative pain and functional outcome. This is evaluate with computerized tomographic.

Study contacts

Contact information is provided by the study sponsor or research team.

Miguel Ángel Ruiz Iban, MD, PhD

CONTACT

[email protected]

655668479

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2022
Registry last updated
Sep 19, 2024

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.