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Clinical Trials in Canada / NCT02038140
Active, not recruiting Not applicable

Zimmer Trabecular Metal Total Ankle PMCF

NCT02038140 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2014-03
Last updated
2026-07-09

Condition(s) studied

Degenerative ArthritisRheumatoid ArthritisPost Traumatic Arthritis

Investigational drug(s) / intervention(s)

Zimmer Trabecular Metal Total Ankle System

Zimmer Trabecular Metal Total Ankle System: Primary or revision total ankle replacement

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 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

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
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 Finland
Klinikverbund St. Antonius und St. Josef GmbH Wuppertal Germany
Humanitas San Pio X Milan Milano MI
Inselspital-Stiftung Universitatsspital Bern Bern Switzerland
Spital StS AG Thun Switzerland

More Zimmer Biomet trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02038140 on ClinicalTrials.gov ↗ ← All trials in Canada