Clinical trial NCT06754150: Shoulder Innovations Clinical Data Registry
Official title: Shoulder Innovations Clinical Data Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Shoulder Arthroplasty
Keywords: Shoulder Arthroplasty
Shoulder Replacement
Anatomic Shoulder Arthroplasty
Reverse Shoulder Arthroplasty
Lead sponsor: Shoulder Innovations
Sponsor class: INDUSTRY
First posted: 2024-12-31
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (at least 18 years of age) of any gender undergoing a shoulder arthroplasty for any diagnosis/condition with at least one SI Total Shoulder System component enrolled at participating sites

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.

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.

Primary outcomes:
measure: Durability of the device component implant
timeFrame: From the implant procedure until 10 years post-operatively
Secondary outcomes:
measure: Change in range of motion (ROM) post-operatively at specified timepoints as compared to baseline
timeFrame: From baseline (pre-operatively) until 10 years post-operatively
measure: Change in ASES score post-operatively at specified timepoints as compared to baseline
timeFrame: From baseline (pre-operatively) until 10 years post-operatively
measure: Change in SANE score post-operatively at specified timepoints as compared to baseline
timeFrame: From baseline (pre-operatively) until 10 years post-operatively
measure: Change in PROMIS Global-10 score post-operatively at specified timepoints as compared to baseline
timeFrame: From baseline (per-operatively) until 10 years post-operatively
measure: Evaluation of radiographic images for radiolucent lines, implant stability and loosening
timeFrame: From baseline (pre-operatively) until 10 years post-operatively
measure: Rate of intra-operative and post-operative adverse device effects (ADEs)/complications
timeFrame: From the implant procedure until 10 years post-operatively
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Orthopaedics
state: California
city: Denver
country: United States
facility: Western Orthopaedics
state: Colorado
city: Duxbury
country: United States
facility: Plymouth Bay Orthopaedic Associates
state: Massachusetts
Study officials:
References: