Actively Recruiting
FX Shoulder Solutions Retrospective / Prospective Clinical Study
Led by FX Shoulder Solutions · Updated on 2023-10-12
600
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate patient outcomes after shoulder replacement surgery using medical devices made and distributed by FX Shoulder Solutions. The study focuses on understanding the effectiveness, safety, and long-term success of these devices. Data collected will help meet regulatory requirements and support public sharing through presentations and publications. Participants include individuals who have received shoulder replacement implants from FX Shoulder Solutions between January 1, 2018, and June 30, 2023. The study collects clinical information retrospectively from patient records and prospectively through scheduled follow-up evaluations after enrollment. These evaluations follow specific postoperative intervals to monitor the patient's progress. During the study, patients will undergo various assessments including patient-reported outcome surveys, range of motion tests, and pain measurements using validated scales. Researchers will track surgical interventions, device-related side effects, and serious adverse events up to 10 years after surgery. Radiographic reviews will also be conducted at multiple time points to assess implant status and longevity.
CONDITIONS
Brief Title
FX Shoulder Solutions Retrospective / Prospective Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Received an FX Shoulder Solutions replacement medical device based on surgeon's standard of care between January 1, 2018, and June 30, 2023.
You will not qualify if you...
- Patients who do not meet the inclusion criteria above.
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.
1 visit (in-person)
Duration - Baseline visit
Participants undergo evaluation including review of clinical data, surgical procedure details, and implant components collected retrospectively and at baseline.
1 baseline visit (in-person)
Duration - Up to 10 years postoperative
Participants are evaluated prospectively with clinical data collected at defined postoperative intervals to assess effectiveness, safety, and survivorship of the shoulder replacement devices.
Visits at 3, 6, 12, 24 months, 5 years, and 10 years postoperative
Trial Site Locations
Total: 2 locations
1
OrthoArizona
Gilbert, Arizona, United States, 85297
Not Yet Recruiting
2
Advanced Orthopedics Institute
The Villages, Florida, United States, 32159
Actively Recruiting
Research Team
T
Ted McKittrick, BA
B
Brian Rogers, BS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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