RECRUITING

MDR - Comprehensive Primary Revision Stems PMCF

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 objective of this retrospective and prospective consecutive series PMCF (Post Market Clinical Follow Up) study is to collect long-term data confirming safety, performance and clinical benefits of the Comprehensive Primary Revision Stems (implants and instrumentation) when used for shoulder arthroplasty at 1, 3, 5, 7 and 10 years.

Official Title

Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive® Primary Revision Stems (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study

Quick Facts

Study Start:2025-06-19
Study Completion:2040-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06788717

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 to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Octavia Gladden
CONTACT
7044930178
octavia.gladden@zimmerbiomet.com

Principal Investigator

Ryan Boylan, MBA
STUDY_DIRECTOR
Zimmer Biomet

Study Locations (Sites)

Cedars Sinai Medical Center
Los Angeles, California, 900033
United States

Collaborators and Investigators

Sponsor: Zimmer Biomet

  • Ryan Boylan, MBA, STUDY_DIRECTOR, Zimmer Biomet

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 Date2025-06-19
Study Completion Date2040-12

Study Record Updates

Study Start Date2025-06-19
Study Completion Date2040-12

Terms related to this study

Additional Relevant MeSH Terms

  • Shoulder Pain
  • Shoulder Injuries
  • Shoulder Fractures
  • Shoulder Disease
  • Shoulder Arthritis