Recruiting

Observational Study

Sponsor:

Shoulder Innovations

Code:

NCT06754150

Conditions

Shoulder Arthroplasty

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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).

Conditions

Shoulder Arthroplasty

Study ID

NCT06754150

Start date

Oct 23, 2024

Status verified date

Sep, 2026

Completion date

Dec, 2039

Anticipated

Primary completion date

Dec, 2039

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Durability of the device component implant [ Time Frame: From the implant procedure until 10 years post-operatively ]

Central Contacts and Locations

Locations

St. Vincent's Orthopedics

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

Principal Investigator:

David Adkison, MD

California Pacific Orthopaedics

Recruiting

San Francisco, California, United States, 94118

Contacts

Principal Investigator:

Mark A Schrumpf, MD

Western Orthopaedics

Recruiting

Denver, Colorado, United States, 80222

Contacts

Principal Investigator:

Benjamin W Sears, MD

Connolly Orthopedics

Recruiting

Bradenton, Florida, United States, 34208

Contacts

Alexis Connolly, MSN, APRN, FNP-BC

(941) 757-3521alexisc@connollyortho.com

Principal Investigator:

Brendon Connolly, MD

Georgia Bone and Joint

Recruiting

Newnan, Georgia, United States, 30265

Contacts

Principal Investigator:

Michael V Cushing, MD

CAO Southern Maryland Orthopaedics

Recruiting

Leonardtown, Maryland, United States, 20650

Contacts

Principal Investigator:

Peter Johnston, MD

North Shore Physicians Group

Recruiting

Peabody, Massachusetts, United States, 01960

Contacts

Principal Investigator:

Ryan W Churchill, MD

Associated Orthopedists of Detroit

Recruiting

Troy, Michigan, United States, 48083

Contacts

Shariff K. Bishai, DO

248-952-8080

Principal Investigator:

Shariff K. Bishai, DO

More Information

Sponsor

Shoulder Innovations

Last update posted

Sep 10, 2026

Last verified

Sep, 2026

Keywords

  • Shoulder Arthroplasty
  • Shoulder Replacement
  • Anatomic Shoulder Arthroplasty
  • Reverse Shoulder Arthroplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Shoulder Innovations on 2026-09-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.