Clinical trial NCT02038140: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Degenerative Arthritis
Rheumatoid Arthritis
Post Traumatic Arthritis
Keywords: Primary Ankle Replacement
Total Ankle Arthroplasty
Total Ankle Replacement
Trabecular Metal Total Ankle
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2014-01-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Survivorship
timeFrame: 10 years
Secondary outcomes:
measure: American Orthopaedic Foot and Ankle Society Score
timeFrame: First 2 years
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University California Davis
state: California
city: Grand Rapids
country: United States
facility: Orthopaedic Associates of Grand Rapids REI
state: Michigan
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: The Rothman Institute
state: Pennsylvania
city: Vancouver
country: Canada
facility: UBC Providence Health Care Research Institute
state: British Columbia
city: Turku
country: Finland
facility: Turku University Hospital Finland
city: Wuppertal
country: Germany
facility: Klinikverbund St. Antonius und St. Josef GmbH
city: Milan
country: Italy
facility: Humanitas San Pio X
state: Milano MI
city: Bern
country: Switzerland
facility: Inselspital-Stiftung Universitatsspital Bern
city: Thun
country: Switzerland
facility: Spital StS AG
Study officials:
affiliation: Zimmer Biomet
name: Hillary Overholser, MS
role: STUDY_DIRECTOR
References: