Shoulder Innovations Clinical Data Registry
SICDR
1 other identifier
observational
2,500
1 country
6
Brief Summary
The goal of this multi-center observational study is to collect long-term clinical outcome information for anatomic and reverse total shoulder arthroplasty (shoulder replacement).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2024
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 23, 2024
CompletedFirst Submitted
Initial submission to the registry
December 13, 2024
CompletedFirst Posted
Study publicly available on registry
December 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2039
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2039
January 22, 2026
January 1, 2026
15.1 years
December 13, 2024
January 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Durability of the device component implant
Assessment of the SI device component will be made at specified intervals using x-rays to check how long the device component can stay implanted with or without a revision surgery.
From the implant procedure until 10 years post-operatively
Secondary Outcomes (6)
Change in range of motion (ROM) post-operatively at specified timepoints as compared to baseline
From baseline (pre-operatively) until 10 years post-operatively
Change in ASES score post-operatively at specified timepoints as compared to baseline
From baseline (pre-operatively) until 10 years post-operatively
Change in SANE score post-operatively at specified timepoints as compared to baseline
From baseline (pre-operatively) until 10 years post-operatively
Change in PROMIS Global-10 score post-operatively at specified timepoints as compared to baseline
From baseline (per-operatively) until 10 years post-operatively
Evaluation of radiographic images for radiolucent lines, implant stability and loosening
From baseline (pre-operatively) until 10 years post-operatively
- +1 more secondary outcomes
Eligibility Criteria
Adult patients (at least 18 years of age) of any gender undergoing a shoulder arthroplasty for any diagnosis/condition with at least one SI Total Shoulder System component enrolled at participating sites
You may qualify if:
- At least 18 years of age.
- Plan to receive or has received a shoulder arthroplasty surgical procedure, with a minimum of one implanted Shoulder Innovations (SI) device component and be willing and able to complete post-operative visits as long as at least one SI device component remains implanted.
- Able to provide informed consent prior to enrollment in the study (unless a waiver has been obtained).
- Agree to and be able to consistently answer the specified Patient Reported Outcome Measures (PROM) pre-operatively and at each of the post-operative visits without the use of a translator.
- Willing and able to comply with the requirements of the study protocol
You may not qualify if:
- Participation in a clinical trial of an investigational drug or device that would confound the results of this trial. Participation in another observational registry is allowed provided there are no conflicting requirements to this trial.
- Incarceration.
- Any conditions, co-morbidities, restrictions, or obligations that would prohibit them from complying with the requirements of this study protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
St. Vincent's Orthopedics
Birmingham, Alabama, 35205, United States
California Pacific Orthopaedics
San Francisco, California, 94118, United States
Western Orthopaedics
Denver, Colorado, 80222, United States
Connolly Orthopedics
Bradenton, Florida, 34208, United States
Georgia Bone and Joint
Newnan, Georgia, 30265, United States
North Shore Physicians Group
Peabody, Massachusetts, 01960, United States
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2024
First Posted
December 31, 2024
Study Start
October 23, 2024
Primary Completion (Estimated)
December 1, 2039
Study Completion (Estimated)
December 1, 2039
Last Updated
January 22, 2026
Record last verified: 2026-01