Zimmer Trabecular Metal Total Ankle PMCF

Sponsor

Zimmer Biomet (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02038140

Collaborator

(none)

120

Enrollment

Locations

Arm

156

Duration (Months)

10.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Degenerative Arthritis Rheumatoid Arthritis Post Traumatic Arthritis	Device: Zimmer Trabecular Metal Total Ankle System	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2014

Anticipated Primary Completion Date :

Mar 1, 2027

Anticipated Study Completion Date :

Mar 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Other: Zimmer TM Total Ankle System Primary or revision total ankle arthroplasty subjects that receive the Zimmer Trabecular Metal Total Ankle System	Device: Zimmer Trabecular Metal Total Ankle System Primary or revision total ankle replacement Other Names: Primary Ankle Replacement Total Ankle Arthroplasty Total Ankle Replacement

Arm

Intervention/Treatment

Other: Zimmer TM Total Ankle System

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

Device: Zimmer Trabecular Metal Total Ankle System

Primary or revision total ankle replacement

Other Names:

Primary Ankle Replacement

Total Ankle Arthroplasty

Total Ankle Replacement

Outcome Measures

Primary Outcome Measures

Survivorship [10 years]
Survival of the implants after 10 years which is based on removal of the prosthesis and will be determined using the Kaplan Meier Method.

Secondary Outcome Measures

American Orthopaedic Foot and Ankle Society Score [First 2 years]
Performance os the Zimmer Trabecular Metal Ankle after 2 years which is assessed by the AOFAS score.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University California Davis	Sacramento	California	United States	95817
2	Orthopaedic Associates of Grand Rapids REI	Grand Rapids	Michigan	United States	49503
3	OrthoCarolina Research Institute	Charlotte	North Carolina	United States	28207
4	Duke University	Durham	North Carolina	United States	27705-4677
5	The Rothman Institute	Philadelphia	Pennsylvania	United States	19107
6	UBC Providence Health Care Research Institute	Vancouver	British Columbia	Canada	V6Z 1Y6
7	Turku University Hospital Finland	Turku		Finland
8	Klinikverbund St. Antonius und St. Josef GmbH	Wuppertal		Germany
9	Humanitas San Pio X	Milan	Milano MI	Italy	20159
10	Inselspital-Stiftung Universitatsspital Bern	Bern		Switzerland	3010
11	Spital StS AG	Thun		Switzerland