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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Primary or revision total ankle replacement
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
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.
Time frame: 10 years
American Orthopaedic Foot and Ankle Society Score
Performance os the Zimmer Trabecular Metal Ankle after 2 years which is assessed by the AOFAS score.
Time frame: First 2 years
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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
...and 1 more locations