Implantation of a Reverse Shoulder Prosthesis
Conditions
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.
Interventions
None listed
Sponsors
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. Translated with www.DeepL.com/Translator (free version)
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety and the clinical and radiological outcome of Embrace primary reverse shoulder prostheses. | 24 months | survival at 2-year follow-up with computerized tomografhic |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| security | 24 months | 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. |
| efficiency | 24 months | To evaluate the effect of the Embrace Reverse Embrace arthroplasty on postoperative pain and functional outcome. This is evaluate with computerized tomographic. |
Countries
Spain
Contacts
Primary ContactMiguel Ángel Ruiz Iban, MD, PhD
Outcome results
None listed