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NCT02038140Active, not recruiting

Zimmer Trabecular Metal Total Ankle PMCF

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

Source: ClinicalTrials.gov · Last updated 9 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
120 (estimated)
First submitted
14 Jan 2014
Start date
Mar 2014
Primary completion date
Sept 2027
Lead sponsor
Zimmer Biomet
NCT number
NCT02038140

What you commit to

  • Study type: Interventional
  • Planned participants: 120
  • From Mar 2014 to the primary completion date, Sept 2027
  • 11 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 a previous history of infection in the affected joint

Other illness

  • 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 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

Other

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

Who the study is looking for

  • The patient is \> 18 years of age
  • The patient is skeletally mature
  • The patient qualifies for primary or revision total ankle replacement based on physical exam and medical history including the following: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis.
  • The patient is willing and able to provide written informed consent
  • Patient is willing and able to cooperate in the required post-operative therapy
  • The patient is willing and able to complete scheduled follow-up evaluations questionnaires as described in the Informed Consent
  • The patient has participated in the Informed Consent process and has signed the Institutional Review Board/European Commission approved Informed Consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (11)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UBC Providence Health Care Research Institute
Coordinator of this site? Confirm its status
VancouverCanadaUnknown status
Inselspital-Stiftung Universitatsspital Bern
Coordinator of this site? Confirm its status
BernSwitzerlandUnknown status
Spital STS AG
Coordinator of this site? Confirm its status
ThunSwitzerlandUnknown status
Klinikverbund St. Antonius und St. Josef GmbH
Coordinator of this site? Confirm its status
WuppertalGermanyUnknown status
Turku University Hospital Finland
Coordinator of this site? Confirm its status
TurkuFinlandUnknown status
Humanitas San Pio X
Coordinator of this site? Confirm its status
MilanItalyUnknown status
OrthoCarolina Research Institute
Coordinator of this site? Confirm its status
CharlotteUnited StatesUnknown status
Duke University
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status
Orthopaedic Associates of Grand Rapids REI
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesUnknown status
The Rothman Institute
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
University California Davis
Coordinator of this site? Confirm its status
SacramentoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.