Shoulder Innovations Clinical Data Registry
ConditionShoulder Arthroplasty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShoulder Innovations
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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-operativelySecondary outcomes
1
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-operatively2
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-operatively3
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-operatively4
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-operativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov