Primary and Fracture Shoulder System Study

Full Title of Study

An Open Label, Multi-Center, Prospective Clinical Outcomes Data Collection to Evaluate the Equinoxe™ Primary and Fracture Shoulder Systems (R#05-144)

Purpose of Study

The Equinoxe™ Shoulder System is indicated to relieve pain and restore function in adults with degenerative diseases or fracture of the shoulder area as determined by the treating surgeon. The purpose of this study is to collect information on the long-term use of Equinoxe™ shoulder replacement in order to better understand the treatment of shoulder problems.

Basic Inclusion Criteria (requirements for being included in study)

  • Age 21 years or older
  • Candidate for shoulder joint replacement

Basic Exclusion Criteria (reasons for being excluded from study)

  • Age, weight, or activity level that would cause the surgeon to expect early failure of the system
  • History of alcohol, drug, or other substance abuse
  • Any disease state that could adversely affect the function or longevity of the implant

Study Visit Requirements

Patients are evaluated preoperatively and will complete a questionnaire on their pain, disability, and quality of life at the time of surgery and postoperatively weekly at approximately 6 weeks, 3 months, 6 months, 12 months, and annually thereafter.

Principal Investigator

Young Kwon, MD

Answers to frequently asked questions (FAQs) about clinical trials

For more information about enrolling in this study, please contact Cara Fontaine, or 212-598-6521