Zimmer Trabecular Metal Total Ankle PMCF

Rheumatoid Arthritis Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Arthritis
• Degenerative Arthritis
• Osteoarthritis
• Post Traumatic Arthritis
• Rheumatoid Arthritis

• NCT number: NCT02038140
• Study type: Interventional
• Source: Zimmer Biomet
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2014
• Completion date: March 2027