Shoulder Innovations Clinical Data Registry

Shoulder Innovations2,500 enrolled

Overview

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).

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 Type

OBSERVATIONAL

Enrollment

2,500

Conditions

Shoulder Arthroplasty

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

St. Vincent's Orthopedics

Birmingham, Alabama, United States

RECRUITING

St. Vincent's Orthopedics

Birmingham, Alabama, United States

ENROLLING_BY_INVITATION

Outcomes

Primary Outcomes

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.

Time frame: From the implant procedure until 10 years post-operatively

Secondary Outcomes

Change in range of motion (ROM) post-operatively at specified timepoints as compared to baseline

Time frame: From baseline (pre-operatively) until 10 years post-operatively

Change in ASES score post-operatively at specified timepoints as compared to baseline

Patients will complete the ASES questionnaire (American Shoulder and Elbow Surgeons Shoulder Score) to evaluate pain and activities of daily living.

Time frame: From baseline (pre-operatively) until 10 years post-operatively

Change in SANE score post-operatively at specified timepoints as compared to baseline

Patients will complete the SANE questionnaire (Single Assessment Numeric Evaluation) to rate their affected shoulder as a percentage of normal.

Time frame: From baseline (pre-operatively) until 10 years post-operatively

Change in PROMIS Global-10 score post-operatively at specified timepoints as compared to baseline

Patients will complete the PROMIS Global-10 questionnaire (Patient-Reported Outcome Measurement Information System Global-10) to evaluate pain and activities of daily living.

Time frame: From baseline (per-operatively) until 10 years post-operatively

Evaluation of radiographic images for radiolucent lines, implant stability and loosening

Time frame: From baseline (pre-operatively) until 10 years post-operatively

Central Contacts

Alyson Harris

CONTACT

408-667-0535 alyson.harris@shoulderinnovations.com

Michele La Badie

CONTACT

615-603-8110 michele.labadie@shoulderinnovations.com

Data from ClinicalTrials.gov

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