Zimmer Trabecular Metal Total Ankle PMCF

Zimmer Biomet

Status: Active, not recruiting

Conditions: Post Traumatic Arthritis; Degenerative Arthritis; Rheumatoid Arthritis

Treatments: Device: Zimmer Trabecular Metal Total Ankle System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02038140

CSU2011-07E

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Zimmer TM Total Ankle System

Other group

Description:

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

Treatment:

Device: Zimmer Trabecular Metal Total Ankle System