NCT02038140

Zimmer Trabecular Metal Total Ankle PMCF

Prospective Post Market Clinical Follow-Up (PMCF) Study of the Zimmer® Trabecular Metal™ Total Ankle

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Degenerative Arthritis
• Rheumatoid Arthritis
• Post Traumatic Arthritis

Interventions

Type	Name	Description
DEVICE	Zimmer Trabecular Metal Total Ankle System	Primary or revision total ankle replacement

Timeline

• Start date: 2014-03-01
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2014-01-16
• Last updated: 2025-10-29

Locations

11 sites across 6 countries: United States, Canada, Finland, Germany, Italy, Switzerland