Actively Recruiting
Shoulder Innovations Clinical Data Registry
Led by Shoulder Innovations · Updated on 2026-05-11
2500
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a non-randomized, multi-center observational study to collect long-term clinical outcome data for patients who have received or plan to receive anatomic or reverse total shoulder arthroplasty using the Shoulder Innovations Total Shoulder System device. The study aims to evaluate both short-term and long-term real-world clinical and radiographic outcomes associated with the use of this shoulder replacement system over a period of up to 10 years after surgery. The study involves collecting standard-of-care data from patients who consent to participate and have at least one Shoulder Innovations device implanted. This includes monitoring the durability of the implant from the time of surgery through 10 years post-operation. Researchers will also assess changes in shoulder range of motion, and patient-reported outcomes using ASES, SANE, and PROMIS Global-10 scores at multiple timepoints from before surgery until 10 years after. Participants will be followed with clinical evaluations, radiographic imaging to check for implant stability and loosening, and assessments of adverse device effects or complications. Patient-reported outcome measures will be completed before surgery and at each postoperative visit. The total duration of participation may extend up to 10 years, allowing comprehensive monitoring of implant performance and patient recovery over time.
CONDITIONS
Brief Title
Shoulder Innovations Clinical Data Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Planning to receive or have received shoulder arthroplasty with at least one Shoulder Innovations device implanted
- Able to provide informed consent before enrollment
- Able to consistently complete patient-reported outcome measures without a translator
- Willing and able to follow the study protocol requirements
You will not qualify if you...
- Participation in another clinical trial of an investigational drug or device that conflicts with this study
- Currently incarcerated
- Any conditions or restrictions that prevent compliance with the study protocol
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 - From implant procedure until hospital discharge
Participants undergo shoulder arthroplasty with a Shoulder Innovations Total Shoulder System device, followed by immediate post-operative care.
1 surgery visit and several immediate post-operative visits
Duration - Up to 10 years post-operatively
Participants are followed for clinical and radiographic outcomes, including range of motion, patient-reported scores, and implant durability.
Multiple follow-up visits over 10 years
Trial Site Locations
Total: 8 locations
1
St. Vincent's Orthopedics
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
St. Vincent's Orthopedics
Birmingham, Alabama, United States, 35205
Enrolling by Invitation
3
California Pacific Orthopaedics
San Francisco, California, United States, 94118
Actively Recruiting
4
Western Orthopaedics
Denver, Colorado, United States, 80222
Actively Recruiting
5
Connolly Orthopedics
Bradenton, Florida, United States, 34208
Actively Recruiting
6
Georgia Bone and Joint
Newnan, Georgia, United States, 30265
Actively Recruiting
7
North Shore Physicians Group
Peabody, Massachusetts, United States, 01960
Actively Recruiting
8
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Enrolling by Invitation
Research Team
A
Alyson Harris
M
Michele La Badie
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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