Zimmer Trabecular Metal Total Ankle PMCF

August 26, 2023 updated by: Zimmer Biomet

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • UBC Providence Health Care Research Institute
  • Finland
      • Turku, Finland
        • Turku University Hospital Finland
  • Germany
      • Wuppertal, Germany
        • Klinikverbund St. Antonius und St. Josef GmbH
  • Italy
    • Milano MI
      • Milan, Milano MI, Italy, 20159
        • Humanitas San Pio X
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital-Stiftung Universitatsspital Bern
      • Thun, Switzerland
        • Spital STS AG
  • United States
    • California
      • Sacramento, California, United States, 95817
        • University California Davis
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Orthopaedic Associates of Grand Rapids REI
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina Research Institute
      • Durham, North Carolina, United States, 27705-4677
        • Duke University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • The Rothman Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Zimmer TM Total Ankle System
Primary or revision total ankle arthroplasty subjects that receive the Zimmer Trabecular Metal Total Ankle System
Device: Zimmer Trabecular Metal Total Ankle System
Primary or revision total ankle replacement
Other Names:
  • Primary Ankle Replacement
  • Total Ankle Arthroplasty
  • Total Ankle Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Orthopaedic Foot and Ankle Society Score
Time Frame: First 2 years
Performance os the Zimmer Trabecular Metal Ankle after 2 years which is assessed by the AOFAS score.
First 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Director: Erin Osborn, MBA, Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 14, 2014

First Posted (Estimated)

January 16, 2014

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 26, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSU2011-07E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Zimmer Trabecular Metal Total Ankle System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe