Actively Recruiting
A Monocentric Clinical Study Evaluating Clinical and Patient-reported Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless
Led by Arthro Medics AG · Updated on 2024-07-31
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical, radiographical, and patient-reported outcomes of SMR Stemless Reverse Shoulder Arthroplasty used as a standard treatment for conditions like rotator cuff tear arthropathy and osteoarthritis of the shoulders. The study includes both retrospective and prospective groups and aims to assess the incidence of any complications over at least two years of follow-up. The study follows patients at standard care time points: baseline, 6 weeks, 6 months, 12 months, and 24 months after surgery. These visits are used to monitor the shoulder arthroplasty outcomes without additional interventions beyond usual care. Both clinical evaluations and imaging are used to track implant stability and related measures. Participants will undergo assessments including the Subjective Shoulder Value score and other shoulder function scores up to 5 years after surgery. Radiographic evaluations for implant loosening and stability are performed at 1 year. Patient-reported pain and function questionnaires are collected during follow-up. The study involves monitoring for complications and collecting data on patient experiences over time.
CONDITIONS
Brief Title
Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of rotator-cuff arthropathy or osteoarthritis
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Female patients who are pregnant, nursing, or planning a pregnancy
- Any adult patient with contraindications to SMR Stemless Reverse Shoulder Arthroplasty as stated in the current local instructions for use
- Patients who do not consent to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 months
Participants who have undergone SMR Stemless Reverse Shoulder Arthroplasty are observed to evaluate clinical, patient-reported, and radiographical outcomes.
Baseline and postoperative visits at 6 weeks, 6 months, 12 months, and 24 months
Trial Site Locations
Total: 1 location
1
Arthro Medics AG
Basel, Canton of Basel-City, Switzerland, 4054
Actively Recruiting
Research Team
C
Claudio Rosso, PD Dr. med
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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