NCT04594993

INFINITY™ With ADAPTIS™ Technology Study

Study Contact:

Rebecca Gibson - Role: CONTACT - Phone: 919-915-4426 - Email: rebecca.gibson@stryker.com
Francis Richards - Role: CONTACT - Phone: (346) 620-8764 - Email: francis.richards@stryker.com

Study Phase:

Recruitment Status:

ACTIVE_NOT_RECRUITING

NCT ID:

NCT04594993

Principal Investigator:

Study Type:

OBSERVATIONAL

Official Title:

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

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

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

Disease(s) and\or Condition(s)

Arthritis, Rheumatoid

Primary Purpose

Intervention/Treatment

- Type: DEVICE
- Name: INFINITY™ with ADAPTIS™ Technology Total Ankle System
- Description: Total Ankle Replacement
- Arm Group Labels:

Sponsor

Stryker Trauma and Extremities