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

NCT ID: NCT05569161

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-24
• Study Completion Date: 2026-10-31

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.

Conditions

Implantation of a Reverse Shoulder Prosthesis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miguel Ángel Ruiz Iban

Role: PRINCIPAL_INVESTIGATOR

IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.

Locations

Miguel Ángel Ruiz Ibán

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Miguel Ángel Ruiz Iban, MD, PhD

Role: CONTACT

drmri@gmail.com

655668479

Facility Contacts

Miguel Ángel RI Ruiz Iban, DR

Role: primary

drmri@hotmail.com

913368208

Other Identifiers

PROTESISHOMBRO02

Identifier Type: -

Identifier Source: org_study_id