Zimmer Trabecular Metal Total Ankle PMCF
Primary Purpose
Degenerative Arthritis, Rheumatoid Arthritis, Post Traumatic Arthritis
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Zimmer Trabecular Metal Total Ankle System
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Arthritis focused on measuring Primary Ankle Replacement, Total Ankle Arthroplasty, Total Ankle Replacement, Trabecular Metal Total Ankle
Eligibility Criteria
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
Sites / Locations
- University California Davis
- Orthopaedic Associates of Grand Rapids REI
- OrthoCarolina Research Institute
- Duke University
- The Rothman Institute
- UBC Providence Health Care Research Institute
- Turku University Hospital Finland
- Klinikverbund St. Antonius und St. Josef GmbH
- Humanitas San Pio X
- Inselspital-Stiftung Universitatsspital Bern
- Spital StS AG
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Zimmer TM Total Ankle System
Arm Description
Primary or revision total ankle arthroplasty subjects that receive the Zimmer Trabecular Metal Total Ankle System
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
American Orthopaedic Foot and Ankle Society Score
Performance os the Zimmer Trabecular Metal Ankle after 2 years which is assessed by the AOFAS score.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02038140
Brief Title
Zimmer Trabecular Metal Total Ankle PMCF
Official Title
Prospective Post Market Clinical Follow-Up (PMCF) Study of the Zimmer® Trabecular Metal™ Total Ankle
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
March 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Arthritis, Rheumatoid Arthritis, Post Traumatic Arthritis
Keywords
Primary Ankle Replacement, Total Ankle Arthroplasty, Total Ankle Replacement, Trabecular Metal Total Ankle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Zimmer TM Total Ankle System
Arm Type
Other
Arm Description
Primary or revision total ankle arthroplasty subjects that receive the Zimmer Trabecular Metal Total Ankle System
Intervention Type
Device
Intervention Name(s)
Zimmer Trabecular Metal Total Ankle System
Other Intervention Name(s)
Primary Ankle Replacement, Total Ankle Arthroplasty, Total Ankle Replacement
Intervention Description
Primary or revision total ankle replacement
Primary Outcome Measure Information:
Title
Survivorship
Description
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
Secondary Outcome Measure Information:
Title
American Orthopaedic Foot and Ankle Society Score
Description
Performance os the Zimmer Trabecular Metal Ankle after 2 years which is assessed by the AOFAS score.
Time Frame
First 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Osborn, MBA
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
University California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Orthopaedic Associates of Grand Rapids REI
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
OrthoCarolina Research Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705-4677
Country
United States
Facility Name
The Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
UBC Providence Health Care Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Turku University Hospital Finland
City
Turku
Country
Finland
Facility Name
Klinikverbund St. Antonius und St. Josef GmbH
City
Wuppertal
Country
Germany
Facility Name
Humanitas San Pio X
City
Milan
State/Province
Milano MI
ZIP/Postal Code
20159
Country
Italy
Facility Name
Inselspital-Stiftung Universitatsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Spital StS AG
City
Thun
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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Zimmer Trabecular Metal Total Ankle PMCF
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