Zimmer Trabecular Metal Total Ankle PMCF

Running, not enrolling · Not applicable

Conditions studied: Degenerative Arthritis, Rheumatoid Arthritis, Post Traumatic Arthritis

In brief

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.

Key facts

Study ID

NCT02038140

Run by

Zimmer Biomet

People needed

120

Starts

2014-03-01

Expected to finish

2027-12-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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