INFINITY™ With ADAPTIS™ Technology Study

Arthritis, Rheumatoid Clinical Trial

— ITAR2  

Official title:

INFINITY™ With ADAPTIS™ Technology Total Ankle Replacement Follow-Up

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04594993
• Other study ID #: US20-TAR-001
• Status: Recruiting
• Start date: February 9, 2021
• Est. completion date: November 2035

Study information

• Verified date: February 2024
• Source: Stryker Trauma GmbH
• Contact: Rebecca Gibson
• Phone: 919-915-4426
• Email: rebecca.gibson[@]stryker.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

INFINITY™ with ADAPTIS™ Technology Total Ankle Replacement Follow-up (ITAR2) - 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 200 patients with up to 13 sites

Description:

The selected design is a multi-center, non-randomized, prospective study of 200 subjects in the US with up to 13 investigational sites and a potential for more as needed to meet the enrollment requirements. The study subjects included are those with ankle joints damaged by severe rheumatoid arthritis, post-traumatic disease, and degenerative arthritis and implanted with the INFINITY™ With ADAPTIS™ Technology Total Ankle System.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2035
• Est. primary completion date: November 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Be over 22 years of age 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™ with ADAPTIS™ Technology Total Ankle System replacement prior to enrollment.

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

Intervention

Device:
• INFINITY™ with ADAPTIS™ Technology Total Ankle System
Total Ankle Replacement

Locations

Country	Name	City	State
United States	University of Colorado Orthopedic Research Center	Aurora	Colorado
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Erlanger Institute for Clinical Research	Chattanooga	Tennessee
United States	Slocum Center for Orthopedics & Sports Medicine	Eugene	Oregon
United States	Campbell Clinic	Germantown	Tennessee
United States	OrthoArizona Foot and Ankle Institute	Gilbert	Arizona
United States	Loyola University Medical Center	Maywood	Illinois
United States	Southern Oregon Orthopedics	Medford	Oregon
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Hospital for Special Surgery	New York	New York
United States	Eisenhower Health / Desert Orthopedic Center	Rancho Mirage	California
United States	Florida Joint Care Institute	Trinity	Florida
United States	Steadman Philippon Research Institute	Vail	Colorado

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	Measure survivorship of INFINITY™ with ADAPTIS™ Technology Total Ankle System at 10 years	Assess the 10-year survivorship of 200 patients implanted with the INFINITY™ with ADAPTIS™ Technology Total Ankle System is non-inferior to other, similar devices.	10 years
Secondary	Radiographic Evaluation- Physician Reported Questionnaire	Identify and assess the implant for component loosening and/or subsidence, any radiolucency and/or cyst formation through radiographic evaluation early and throughout the lifetime of the implant.	10 years
Secondary	PROMIS® Global Health Questionnaire	Compare the improvements in self-reported physical, mental, and social health measures from pre-op through 10 years post operatively; assessed by PROMIS® Global HealthThe PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "TScore" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.	10 years
Secondary	Ankle Osteoarthritis Score (AOS) Questionnaire	Compare pain and functional improvement in the Ankle Osteoarthritis Score (AOS). AOS is a reliable, validated, visual analog-based,AOS is a reliable, validated, visual analog-based, disease-specific self-administered instrument designed specifically to measure disability and pain from ankle osteoarthritis. Both Pain and Disability components are used to calculate the total score. The score is from zero to one hundred with a lower score indicating more normal function. A minimal clinically important difference (MCID) for the Total AOS score reduction from baseline has been established: 12.35 points.	10 years
Secondary	Foot & Ankle Observational Score (FAOS) questionnaire.	Compare the improvement in patient/physician reported function scores from pre-op through 10 years post-operatively, assessed by the Foot & Ankle Observational Score (FAOS) questionnaire. The FAOS is a self-report measure that evaluates symptoms and functional limitations in individuals with generalized foot and ankle disorders. Items for the FAOS were adapted from the Knee Injury and Osteoarthritis Outcome Score. The FAOS is composed of the following 5 subscales: pain (9 items), other symptoms (7 items), activities of daily living (7 items), sports and recreational activities (5 items), and foot and ankle-related quality of life (4 items). Each subscale has a potential range from 0 to 100. Where 100 indicates no problems and 0 indicates extreme problems.	10 years
Secondary	Patient Satisfaction of Total Ankle Replacement (TAR)	Compare patient satisfaction of total ankle replacement (TAR) post operatively utilizing a four-point scale.	10 years