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

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status: Enrolling

Conditions: Implantation of a Reverse Shoulder Prosthesis

Study type: Observational

Funder types: Other

Identifiers

NCT05569161

PROTESISHOMBRO02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.