RECRUITING

Perform Humeral System Study

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

This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation. Data collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and/or product development.

Official Title

Perform Humeral System Study

Quick Facts

Study Start:2021-09-12
Study Completion:2035-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05067543

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:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years or older at the time of the informed consent or non-opposition (when applicable).
  2. * Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).
  3. * Willing and able to comply with the requirements of the study protocol.
  4. * Considered a candidate for shoulder arthroplasty using a study device.
  5. * Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements
  1. * Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)
  2. * Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm).
  3. * Active local or systemic infection, sepsis, or osteomyelitis
  4. * Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid
  5. * Significant injury to the brachial plexus
  6. * Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
  7. * Neuromuscular disease (e.g., joint neuropathy)
  8. * Patient with known allergy to one of the product materials
  9. * Metabolic disorders which may impair bone formation
  10. * Patient pregnancy
  11. * Planned for two-stage surgery

Contacts and Locations

Study Contact

Meredith Schreier
CONTACT
901-232-2704
meredith.schreier@stryker.com
Amjad Uneisi
CONTACT
amjad.uneisi@stryker.com

Principal Investigator

Rebecca Gibson
STUDY_DIRECTOR
Stryker Trauma

Study Locations (Sites)

Baptist Healthcare
Lexington, Kentucky, 40503
United States
Summit Orthopedics
Eagan, Minnesota, 55121
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Washington University
Saint Louis, Missouri, 63110
United States
Orthopedic Institute
Sioux Falls, South Dakota, 57105
United States
University of Utah
Salt Lake City, Utah, 84108
United States

Collaborators and Investigators

Sponsor: Stryker Trauma and Extremities

  • Rebecca Gibson, STUDY_DIRECTOR, Stryker Trauma

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 Date2021-09-12
Study Completion Date2035-12-01

Study Record Updates

Study Start Date2021-09-12
Study Completion Date2035-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Osteoarthritis Shoulder
  • Avascular Necrosis
  • Post-traumatic Arthrosis of Other Joints, Shoulder Region
  • Rotator Cuff Tear Arthropathy