Ankle Implant for Arthritis

Recruiting at10 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Zimmer Biomet

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial studies a special ankle implant for patients needing ankle surgery. It aims to see how well the implant works in reducing pain and improving function. The implants have been developed to improve stability and longevity, with advancements in design and materials.

Research Team

Hillary Overholser, MS

Principal Investigator

Zimmer Biomet

Eligibility Criteria

This trial is for adults over 18 with arthritis (degenerative, rheumatoid, or post-traumatic) who need ankle replacement surgery. They must be able to consent and follow the study's procedures. Excluded are prisoners, those mentally unable to participate, non-compliant individuals, pregnant women, patients with infections or poor bone quality, and those with severe limb issues.

Inclusion Criteria

I am older than 18 years.

The patient is willing and able to provide written informed consent

My bones have stopped growing.

Exclusion Criteria

The patient has a known sensitivity or allergic reaction to one or more of the implanted materials

The patient is unwilling or unable to give consent or to comply with the follow-up program

I am not a prisoner, mentally competent, understand the study, and do not abuse substances.

Treatment Details

Interventions

• Zimmer Trabecular Metal Total Ankle System (Orthopedic Implant)

Trial Overview The Zimmer Trabecular Metal Total Ankle System is being tested in people needing ankle replacements due to arthritis. The study aims to track how well the implant works by looking at pain relief, improved function, life quality measures and checking x-rays for durability.

Participant Groups

Group I: Zimmer TM Total Ankle System Experimental Treatment 1 Intervention

Primary or revision total ankle arthroplasty subjects that receive the Zimmer Trabecular Metal Total Ankle System

Who Is Running the Clinical Trial?

Zimmer Biomet

Lead Sponsor

Trials

383

Recruited

67,800+

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos

Zimmer Biomet

Chief Executive Officer since 2023

MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business