🏛️ Verified NIH Record • Updated 2026-07-08

Zimmer Trabecular Metal Total Ankle PMCF (NCT02038140)

Prospective Post Market Clinical Follow-Up (PMCF) Study of the Zimmer® Trabecular Metal™ Total Ankle

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Zimmer Biomet

🩺 Plain-English Summary (8th-Grade Level)

The primary objective of this study is to obtain implant survivorship and clinical outcome data for commercially available Zimmer Trabecular Metal Total Ankle implants used in primary or revision total ankle arthroplasty. The assessment will include implant survivorship and clinical performance measured by pain and function, quality of life data, radiographic parameters and survivorship.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (9 items).

Location: University California Davis — Sacramento, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • The patient is: a prisoner, mentally incompetent or unable to understand what participation in the study entails, a known alcohol or drug abuser, anticipated to be non-compliant.
  • The patient has one of the following compromising the affected limb: ankle arthrodesis with malleolar exeresis, severe neurological or vascular disease, loss of musculature or neuromuscular compromise, severe instability, maltracking or misalignment of the tibia and talus uncorrectable by surgery.
  • The patient has a local/systemic infection that may affect the prosthetic joint
  • The patient has a previous history of infection in the affected joint
  • The patient is known to be pregnant
  • The patient has insufficient bone stock or bone quality to fix the components (i.e. osteoporosis, Charcot's disease)
  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (11 Sites)

  • University California Davis — Sacramento, California
  • Orthopaedic Associates of Grand Rapids REI — Grand Rapids, Michigan
  • OrthoCarolina Research Institute — Charlotte, North Carolina
  • Duke University — Durham, North Carolina
  • The Rothman Institute — Philadelphia, Pennsylvania
  • UBC Providence Health Care Research Institute — Vancouver, British Columbia
  • Turku University Hospital Finland — Turku,
  • Klinikverbund St. Antonius und St. Josef GmbH — Wuppertal,
  • Humanitas San Pio X — Milan, Milano MI
  • Inselspital-Stiftung Universitatsspital Bern — Bern,
  • Spital StS AG — Thun,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗