Shoulder Innovations Clinical Data Registry

Recruiting

• Conditions: Shoulder Arthroplasty

• Registration Number: NCT06754150
• Lead Sponsor: Shoulder Innovations

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).

Detailed Description

The study is a non-randomized, multi-center prospective registry that will collect standard-of-care data for patients who plan to receive or have received shoulder arthroplasty (anatomic or reverse) with a Shoulder Innovations (SI) Total Shoulder System device and consent to participate in the study. The study will evaluate short and long term clinical and radiographic outcomes associated with real-world use of the arthroplasty system from the implant procedure through 10 years post-operatively.

Study Timeline

• Study Start: 2024-10-23
• Status Verified: 2024-12
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Primary Completion: 2039-12
• Study Completion: 2039-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Durability of the device component implant	From the implant procedure until 10 years post-operatively	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.

Secondary Outcome Measures

Name	Time	Method
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	Patients will complete the ASES questionnaire (American Shoulder and Elbow Surgeons Shoulder Score) to evaluate pain and activities of daily living.
Change in SANE score post-operatively at specified timepoints as compared to baseline	From baseline (pre-operatively) until 10 years post-operatively	Patients will complete the SANE questionnaire (Single Assessment Numeric Evaluation) to rate their affected shoulder as a percentage of normal.
Change in PROMIS Global-10 score post-operatively at specified timepoints as compared to baseline	From baseline (per-operatively) until 10 years post-operatively	Patients will complete the PROMIS Global-10 questionnaire (Patient-Reported Outcome Measurement Information System Global-10) to evaluate pain and activities of daily living.
Evaluation of radiographic images for radiolucent lines, implant stability and loosening	From baseline (pre-operatively) until 10 years post-operatively
Rate of intra-operative and post-operative adverse device effects (ADEs)/complications	From the implant procedure until 10 years post-operatively

Trial Locations

Locations (2)

Western Orthopaedics; 🇺🇸 Denver, Colorado, United States

Plymouth Bay Orthopaedic Associates; 🇺🇸 Duxbury, Massachusetts, United States