Evaluating the safety and outcomes of a specific shoulder implant over two years
Prospective Multicentre Longitudinal Study to Evaluate the Safety and Clinical Radiological Outcomes in the First Two Years of the Ambrace Model Reverse Shoulder Arthroplasty.
This study is testing how safe and effective a specific shoulder implant is for patients over two years to see how well it helps with pain and shoulder function.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT05569161 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients receiving an Embrace model reverse shoulder arthroplasty to assess its safety and clinical radiological outcomes over a two-year period. Participants will be closely monitored for complications and the effectiveness of the prosthesis in restoring shoulder function and alleviating pain. The study aims to provide detailed follow-up data on the performance of this specific prosthetic model in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with shoulder joint disorders suitable for treatment with the Embrace reverse arthroplasty.
Not a fit: Patients who have previously undergone shoulder arthroplasty or have an active infection at the time of surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the safety and effectiveness of the Embrace reverse shoulder prosthesis, leading to improved patient outcomes.
How similar studies have performed: Other studies on reverse shoulder arthroplasty have shown promising results, indicating that this approach is not entirely novel but continues to be evaluated for safety and efficacy.
Eligibility criteria
Show full inclusion / exclusion 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. 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.
Where this trial is running
Madrid
- Miguel Ángel Ruiz Ibán — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Miguel Ángel Ruiz Iban — IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.
- Study coordinator: Miguel Ángel Ruiz Iban, MD, PhD
- Email: drmri@gmail.com
- Phone: 655668479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.