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
- Diseases
- Rheumatoid arthritis
- 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
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UBC Providence Health Care Research Institute Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Inselspital-Stiftung Universitatsspital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Spital STS AG Coordinator of this site? Confirm its status | Thun | Switzerland | Unknown status |
| Klinikverbund St. Antonius und St. Josef GmbH Coordinator of this site? Confirm its status | Wuppertal | Germany | Unknown status |
| Turku University Hospital Finland Coordinator of this site? Confirm its status | Turku | Finland | Unknown status |
| Humanitas San Pio X Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| OrthoCarolina Research Institute Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Orthopaedic Associates of Grand Rapids REI Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| The Rothman Institute Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University California Davis Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.