Clinical trial NCT05569161: To Evaluate the Safety and Clinical Radiological Outcomes in 2 Years of Embrance Model Reverse Shoulder Arthroplasty
Official 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Implantation of a Reverse Shoulder Prosthesis
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital care consultations

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

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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.

Primary outcomes:
measure: To assess the safety and the clinical and radiological outcome of Embrace primary reverse shoulder prostheses.
timeFrame: 24 months
Secondary outcomes:
measure: security
timeFrame: 24 months
measure: efficiency
timeFrame: 24 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Miguel Ángel Ruiz Ibán
Study officials:
affiliation: IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.
name: Miguel Ángel Ruiz Iban
role: PRINCIPAL_INVESTIGATOR
References: