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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

hospital care consultations

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

survival at 2-year follow-up with computerized tomografhic

Time frame
24 months

Secondary outcomes

1

security

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.

Time frame
24 months
2

efficiency

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

Time frame
24 months

Other outcomes

Sponsors and contacts

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