RECRUITING

Shoulder Innovations Clinical Data Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Shoulder Innovations Clinical Data Registry

Quick Facts

Study Start:2024-10-23
Study Completion:2039-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06754150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. At least 18 years of age.
  2. 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. 3. Able to provide informed consent prior to enrollment in the study (unless a waiver has been obtained).
  4. 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. 5. Willing and able to comply with the requirements of the study protocol
  1. 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. 2. Incarceration.
  3. 3. Any conditions, co-morbidities, restrictions, or obligations that would prohibit them from complying with the requirements of this study protocol.

Contacts and Locations

Study Contact

Alyson Harris
CONTACT
408-667-0535
alyson.harris@shoulderinnovations.com
Erica Burk
CONTACT
951-265-1554
erica.burk@shoulderinnovations.com

Study Locations (Sites)

Western Orthopaedics
Denver, Colorado, 80218
United States
Plymouth Bay Orthopaedic Associates
Duxbury, Massachusetts, 02332
United States

Collaborators and Investigators

Sponsor: Shoulder Innovations

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-23
Study Completion Date2039-12

Study Record Updates

Study Start Date2024-10-23
Study Completion Date2039-12

Terms related to this study

Keywords Provided by Researchers

  • Shoulder Arthroplasty
  • Shoulder Replacement
  • Anatomic Shoulder Arthroplasty
  • Reverse Shoulder Arthroplasty

Additional Relevant MeSH Terms

  • Shoulder Arthroplasty