Degenerative ArthritisNCT02038140
Zimmer Trabecular Metal Total Ankle PMCF
A study testing Zimmer Trabecular Metal Total Ankle System in people with Degenerative Arthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 11 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Arthritis, Rheumatoid Arthritis, Post Traumatic Arthritis
- What is being tested?
- Zimmer Trabecular Metal Total Ankle System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 11 sitesin 6 countries
- Study dates
- Mar 2014to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
United States5 sites
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
Duke University
Durham, North Carolina, 27705-4677
Orthopaedic Associates of Grand Rapids REI
Grand Rapids, Michigan, 49503
The Rothman Institute
Philadelphia, Pennsylvania, 19107
University California Davis
Sacramento, California, 95817
Switzerland2 sites
Inselspital-Stiftung Universitatsspital Bern
Bern, 3010
Spital StS AG
Thun
Canada1 site
UBC Providence Health Care Research Institute
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Prospective Post Market Clinical Follow-Up (PMCF) Study of the Zimmer® Trabecular Metal™ Total Ankle
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.
Read the detailed description
The study design is a prospective, multicenter, study of the commercially available Zimmer Trabecular Metal Ankle semiconstrained implants. The study will require each site to obtain Institutional Review Board approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
All study subjects will undergo preoperative clinical evaluations prior to their primary or revision total ankle arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6 weeks, 6 month, 1 year, 2, 3, 5, 7, and 10 years. Follow-up surveys will occur at 4, 6, 8, and 9 years.
- Being tested
- Zimmer Trabecular Metal Total Ankle System
- Keywords
- Primary Ankle Replacement, Total Ankle Arthroplasty, Total Ankle Replacement, Trabecular Metal Total Ankle
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zimmer Trabecular Metal Total Ankle SystemDevice
Also called Primary Ankle Replacement, Total Ankle Arthroplasty, Total Ankle Replacement
Primary or revision total ankle replacement
| Study group | Role | What they receive |
|---|---|---|
| Zimmer TM Total Ankle System | Other | Primary or revision total ankle arthroplasty subjects that receive the Zimmer Trabecular Metal Total Ankle System Receives: Device: Zimmer Trabecular Metal Total Ankle System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship
Survival of the implants after 10 years which is based on removal of the prosthesis and will be determined using the Kaplan Meier Method.
Measured: 10 years
Secondary outcomes (1)
American Orthopaedic Foot and Ankle Society Score
Performance os the Zimmer Trabecular Metal Ankle after 2 years which is assessed by the AOFAS score.
Measured: First 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative ArthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hillary Overholser, MS, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038140
- Sponsor's protocol ID
- CSU2011-07E
- Status last verified
- Jul 2026
- First submitted
- 14 Jan 2014
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Post Market Clinical Follow-Up (PMCF) Study of the Zimmer® Trabecular Metal™ Total Ankle
- ClinicalTrials.gov ID
- NCT02038140
- Acronym / sponsor ID
- CSU2011-07E
- Keywords
- Primary Ankle Replacement, Total Ankle Arthroplasty, Total Ankle Replacement, Trabecular Metal Total Ankle
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study design is a prospective, multicenter, study of the commercially available Zimmer Trabecular Metal Ankle semiconstrained implants. The study will require each site to obtain Institutional Review Board approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
All study subjects will undergo preoperative clinical evaluations prior to their primary or revision total ankle arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6 weeks, 6 month, 1 year, 2, 3, 5, 7, and 10 years. Follow-up surveys will occur at 4, 6, 8, and 9 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zimmer TM Total Ankle System | Other | Device: Zimmer Trabecular Metal Total Ankle SystemPrimary or revision total ankle arthroplasty subjects that receive the Zimmer Trabecular Metal Total Ankle System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zimmer Trabecular Metal Total Ankle SystemAlso: Primary Ankle Replacement, Total Ankle Arthroplasty, Total Ankle ReplacementPrimary or revision total ankle replacement | Device | Zimmer TM Total Ankle System |
Primary outcome
Survivorship
Time frame: 10 years
Survival of the implants after 10 years which is based on removal of the prosthesis and will be determined using the Kaplan Meier Method.
1 secondary outcome
American Orthopaedic Foot and Ankle Society Score
Time frame: First 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hillary Overholser, MS study director
Zimmer Biomet
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zimmer Trabecular Metal Total Ankle System in people with Degenerative Arthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 11 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Switzerland, Canada, Finland, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivorship (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.