Menu
Recruiting NCT06754150

Shoulder Innovations Clinical Data Registry

— Observational Shoulder Arthroplasty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Shoulder Arthroplasty. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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).

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.

Primary outcome measures

  • Durability of the device component implant [Time frame: From the implant procedure until 10 years post-operatively]
Secondary outcome measures (6)
  • 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 [Time frame: From baseline (pre-operatively) until 10 years post-operatively]
  • Change in SANE score post-operatively at specified timepoints as compared to baseline [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 [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]
  • Rate of intra-operative and post-operative adverse device effects (ADEs)/complications [Time frame: From the implant procedure until 10 years post-operatively]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 8 centers
  • St. Vincent's Orthopedics — Birmingham
  • St. Vincent's Orthopedics — Birmingham
  • California Pacific Orthopaedics — San Francisco
  • Western Orthopaedics — Denver
  • Connolly Orthopedics — Bradenton
  • Georgia Bone and Joint — Newnan
  • North Shore Physicians Group — Peabody
  • University Medical Center of Southern Nevada — Las Vegas

Identifiers

NCT: NCT06754150 · SICDR 31.0.1.1.1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗