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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02038140
• Other study ID #: CSU2011-07E
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2014
• Est. completion date: March 2027

Study information

• Verified date: May 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Zimmer Trabecular Metal Total Ankle System
Primary or revision total ankle replacement

Locations

Country	Name	City	State
Canada	UBC Providence Health Care Research Institute	Vancouver	British Columbia
Finland	Turku University Hospital Finland	Turku
Germany	Klinikverbund St. Antonius und St. Josef GmbH	Wuppertal
Italy	Humanitas San Pio X	Milan	Milano MI
Switzerland	Inselspital-Stiftung Universitatsspital Bern	Bern
Switzerland	Spital StS AG	Thun
United States	OrthoCarolina Research Institute	Charlotte	North Carolina
United States	Duke University	Durham	North Carolina
United States	Orthopaedic Associates of Grand Rapids REI	Grand Rapids	Michigan
United States	The Rothman Institute	Philadelphia	Pennsylvania
United States	University California Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Canada,  Finland,  Germany,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	American Orthopaedic Foot and Ankle Society Score	Performance os the Zimmer Trabecular Metal Ankle after 2 years which is assessed by the AOFAS score.	First 2 years