STAR Ankle Implant Study

Full Title of Study

Two-Year Post-Approval Study to Investigate the STAR Ankle Under Actual Conditions of Use (R#10-00453)

Purpose of Study

To see how well the Scandinavian Total Ankle Replacement (STAR) ankle implant works in patients using new and improved surgical instruments. The implant is designed to maintain motion of the joint in your ankle like an artificial hip implant does for the leg.

Basic Inclusion Criteria (requirements for being included in study)

  • Age 18 years or older
  • Loss of mobility and function of the ankle
  • Diagnosis of primary arthrosis, posttraumatic arthrosis, or rheumatoid arthrosis

Basic Exclusion Criteria (reasons for being excluded from study)

  • Infection in the ankle joint or adjacent bones
  • Obesity (weighing more than 250 pounds)

Study Visit Requirements

Baseline (initial visit) and at 6 weeks and 6, 12, and 24 months postoperatively

Principal Investigator

Kenneth Mroczek, 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