Zimmer Trabecular Metal Total Ankle PMCF

NCT02038140 | Active Not Recruiting

• 1 other identifier: CSU2011-07E
• Study Type: interventional
• Target: 120
• Locations: 6 countries
• Sites: 11

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.

Conditions

Degenerative Arthritis; Rheumatoid Arthritis; Post Traumatic Arthritis

Keywords

Primary Ankle Replacement; Total Ankle Arthroplasty; Total Ankle Replacement; Trabecular Metal Total Ankle

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• American Orthopaedic Foot and Ankle Society Score

  First 2 years

Study Arms (1)

Zimmer TM Total Ankle System

OTHER

Primary or revision total ankle arthroplasty subjects that receive the Zimmer Trabecular Metal Total Ankle System

Device: Zimmer Trabecular Metal Total Ankle System

Interventions

Zimmer Trabecular Metal Total Ankle System DEVICE

Primary or revision total ankle replacement

Also known as: Primary Ankle Replacement, Total Ankle Arthroplasty, Total Ankle Replacement

Zimmer TM Total Ankle System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (11)

University California Davis

Sacramento, California, 95817, United States

Location

Orthopaedic Associates of Grand Rapids REI

Grand Rapids, Michigan, 49503, United States

Location

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

Duke University

Durham, North Carolina, 27705-4677, United States

Location

The Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

UBC Providence Health Care Research Institute

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Turku University Hospital Finland

Turku, Finland

Location

Klinikverbund St. Antonius und St. Josef GmbH

Wuppertal, Germany

Location

Humanitas San Pio X

Milan, Milano MI, 20159, Italy

Location

Inselspital-Stiftung Universitatsspital Bern

Bern, 3010, Switzerland

Location

Spital StS AG

Thun, Switzerland

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid

Interventions

Arthroplasty, Replacement, Ankle

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Hillary Overholser, MS

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 16, 2014
• Study Start: March 1, 2014
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); FI (1); CA (1); CH (2); US (5); DE (1)