NCT06754150 Shoulder Innovations Clinical Data Registry
| NCT ID | NCT06754150 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shoulder Innovations |
| Condition | Shoulder Arthroplasty |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2024-10-23 |
| Primary Completion | 2039-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,500 participants in total. It began in 2024-10-23 with a primary completion date of 2039-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion Criteria: 1. At least 18 years of age. 2. 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. 3. Able to provide informed consent prior to enrollment in the study (unless a waiver has been obtained). 4. 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. 5. Willing and able to comply with the requirements of the study protocol Exclusion Criteria: 1. 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. 2. Incarceration. 3. Any conditions, co-morbidities, restrictions, or obligations that would prohibit them from complying with the requirements of this study protocol.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06754150 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Shoulder Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06754150 currently recruiting?
Yes, NCT06754150 is actively recruiting participants. Contact the research team at alyson.harris@shoulderinnovations.com for enrollment information.
Where is the NCT06754150 trial being conducted?
This trial is being conducted at Birmingham, United States, Birmingham, United States, San Francisco, United States, Denver, United States and 4 additional locations.
Who is sponsoring the NCT06754150 clinical trial?
NCT06754150 is sponsored by Shoulder Innovations. The trial plans to enroll 2,500 participants.