To Evaluate the Safety and Clinical Radiological Outcomes in 2 Years of Embrance Model Reverse Shoulder Arthroplasty
Recruiting now
Conditions studied: Implantation of a Reverse Shoulder Prosthesis
In brief
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.
Key facts
- Study ID
- NCT05569161
- Run by
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- People needed
- 250
- Starts
- 2022-03-24
- Expected to finish
- 2026-10-31
- Last updated by the study team
- 2024-09-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Miguel Ángel Ruiz Ibán — Madrid, Spain (enrolling)
Full record on ClinicalTrials.gov
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