INFINITY™Total Ankle Replacement Follow-up

Arthritis, Rheumatoid Clinical Trial

— ITAR  

Official title:

INFINITY™Total Ankle Replacement Follow-up

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03277989
• Other study ID #: US17-TAR-001
• Status: Terminated
• Start date: October 9, 2017
• Est. completion date: March 31, 2023

Study information

• Verified date: January 2022
• Source: Stryker Trauma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Study Title INFINITY™Total Ankle Replacement Follow-up (ITAR) Study Design Prospective, multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ Total Ankle System Number of Subjects 150 with 9 sites

Description:

The primary outcome measure of this post-market clinical observational study is to collect data relating to the INFINITY™ Total Ankle System survivorship at 10 years. The secondary outcome measures are to characterize the improvements after implantation over a 10 year period using patient reported outcome measures related to quality of life, pain and functional improvements, safety of the implants, as well as radiographic assessments (X-Rays)

The outcome measures collected in this study will be analyzed and reported as required for local, regional, and country requirements (i.e., regulatory authorities and notified bodies).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 148
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Be 21 years of age or older at the time of surgery;

• Diagnosed with unilateral and/or bilateral ankle joint disease;

• Diagnosed with ankle joint damage from rheumatoid arthritis, post-traumatic, or degenerative arthritis;

• Willing and able to consent to participate (written, informed consent;

• Willing and able to attend the requested follow-up visits;

• A clinical decision has been made to use INFINITY™ Total Ankle System replacement prior to enrollment in the research.

Exclusion Criteria:

• Subjects with an ankle condition, as determined by the investigator, to be an inappropriate candidate for a total ankle replacement;

• Subjects requiring revision total ankle replacement of the ankle being considered for study.

Related Conditions & MeSH terms

• Arthritis, Rheumatoid

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	UT Erlanger	Chattanooga	Tennessee
United States	Slocum Center for Orthopedics & Sports Medicine	Eugene	Oregon
United States	Orthopaedic & Spine Center of the Rockies	Fort Collins	Colorado
United States	Campbell Clinic	Germantown	Tennessee
United States	Orthopaedic Associates of Michigan, PC	Grand Rapids	Michigan
United States	Illinois Bone & Joint Institute	Libertyville	Illinois
United States	Eisenhower Medical Center	Rancho Mirage	California
United States	Beaumont Hospital-Royal Oak	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Trauma GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship of the INFINITY™ Total Ankle System at 10 years	The primary outcome measure of this post-market clinical observational study is to collect data relating to the INFINITY™ Total Ankle System survivorship at 10 years.	10 years
Secondary	Radiographic evaluation-physician reported questionnaire	Identify and assess the implant for component loosening and/or subsidence, any osteolysis and/or cyst formation through radiographic evaluation early and throughout the lifetime of the implant.	Pre-op through 10 years
Secondary	PROMIS® Global Health	Compare the improvements in self-reported physical, mental, and social health measures from pre-op through 10 years post operatively; assessed by PROMIS® Global Health.	Pre-op through 10 years
Secondary	Ankle Osteoarthritis Score (AOS)	Compare pain and functional improvement in the Ankle Osteoarthritis Score (AOS), which is a visual analogue scale specifically designed as a modification of the Foot Function Index.	Pre-op through 10 years
Secondary	FAOS questionnaire	Compare the improvement in patient/physician reported function scores from pre-op through 10 years post-operatively, assessed by the FAOS questionnaire.	Pre-op through 10 years
Secondary	TAR satisfaction questionnaire	Compare satisfaction of total ankle replacement post operatively utilizing a four point scale	Pre-op through 10 years