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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zimmer TM Total Ankle System | Other | Primary or revision total ankle arthroplasty subjects that receive the Zimmer Trabecular Metal Total Ankle System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zimmer Trabecular Metal Total Ankle System | Device | Primary or revision total ankle replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| American Orthopaedic Foot and Ankle Society Score | Performance os the Zimmer Trabecular Metal Ankle after 2 years which is assessed by the AOFAS score. | First 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hillary Overholser, MS | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University California Davis | Sacramento | California | 95817 | United States | ||
| Orthopaedic Associates of Grand Rapids REI |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D058737 | Arthroplasty, Replacement, Ankle |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Grand Rapids |
| Michigan |
| 49503 |
| United States |
| OrthoCarolina Research Institute | Charlotte | North Carolina | 28207 | United States |
| Duke University | Durham | North Carolina | 27705-4677 | United States |
| The Rothman Institute | Philadelphia | Pennsylvania | 19107 | United States |
| UBC Providence Health Care Research Institute | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Turku University Hospital Finland | Turku | Finland |
| Klinikverbund St. Antonius und St. Josef GmbH | Wuppertal | Germany |
| Humanitas San Pio X | Milan | Milano MI | 20159 | Italy |
| Inselspital-Stiftung Universitatsspital Bern | Bern | 3010 | Switzerland |
| Spital StS AG | Thun | Switzerland |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |