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

Prospective Multicentr Longitudinal Study to Evaluate the Safet and Clinical Radiological Outcomes in the First Two Years of the Ambrace 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.

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.

The EMBRACE Reverse Shoulder Arthroplasty System (LINK Spain) is a new model of reverse shoulder prosthesis introduced to the European market in August 2020. It is authorised for use in the treatment of degenerative or traumatic processes of the shoulder in the European Community. It has been in regular use at our centre since October 2020, and more than 50 prostheses of this model have been implanted this year.

There is an ongoing study at the Hospital Universitario Ramón y Cajal, with code PROTESISHOMBRO01, which carries out a prospective registry of all shoulder prostheses implanted at the centre. The present study, PROTESISHOMBRO02, will be carried out in conjunction with this one and differs from the previous one in that: 1.-It carries out a somewhat more exhaustive analysis of a subgroup of the patients included in the PROTESISHOMBRO01 study, and 2. 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.

Study Overview

• Status: Recruiting
• Conditions: Implantation of a Reverse Shoulder Prosthesis

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Recruiting
    • Miguel Ángel Ruiz Ibán
    • Contact: Miguel Ángel RI Ruiz Iban, DR; Phone Number: 913368208; Email: drmri@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

hospital care consultations

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months
efficiency	To evaluate the effect of the Embrace Reverse Embrace arthroplasty on postoperative pain and functional outcome. This is evaluate with computerized tomographic.	24 months

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2022
• Primary Completion (Estimated): March 24, 2024
• Study Completion (Estimated): March 24, 2026

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PROTESISHOMBRO02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No