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ACTIVE NOT RECRUITING

INFINITY™ With ADAPTIS™ Technology Study

NCT04594993 · View on ClinicalTrials.gov ↗

Study 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

Conditions Studied

Interventions

  • DEVICE INFINITY™ with ADAPTIS™ Technology Total Ankle System

Study Locations (13)

Tennessee

  • Erlanger Institute for Clinical Research — Chattanooga
  • Campbell Clinic — Germantown
  • Vanderbilt University Medical Center — Nashville

Colorado

  • University of Colorado Orthopedic Research Center — Aurora
  • Steadman Philippon Research Institute — Vail

Oregon

  • Slocum Center for Orthopedics & Sports Medicine — Eugene
  • Southern Oregon Orthopedics — Medford

Arizona

  • OrthoArizona Foot and Ankle Institute — Gilbert

California

  • Eisenhower Health / Desert Orthopedic Center — Rancho Mirage

Florida

  • Florida Joint Care Institute — Trinity

Illinois

  • Loyola University Medical Center — Maywood

New York

  • Hospital for Special Surgery — New York

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2021-02-09
Est. Completion 2035-11

Sponsor

Stryker Trauma and Extremities

38 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04594993

The ClinicalTrials.gov registry entry for NCT04594993 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stryker Trauma and Extremities, which has 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Arthritis, Rheumatoid appearing as the primary indexed condition, and to 1 intervention — of which INFINITY™ with ADAPTIS™ Technology Total Ankle System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04594993 reports 13 study locations spanning 9 distinct geographic areas — top geographies include Tennessee, Colorado, Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04594993 about?

NCT04594993 is a clinical study titled "INFINITY™ With ADAPTIS™ Technology Study". 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...

What is the current status of trial NCT04594993?

This trial is currently active not recruiting. The enrollment target is 200 participants. The study started on 2021-02-09. Estimated completion is 2035-11.

What conditions does trial NCT04594993 study?

This clinical trial studies the following conditions: Arthritis, Rheumatoid. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04594993?

The interventions under investigation include: INFINITY™ with ADAPTIS™ Technology Total Ankle System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04594993?

This trial is sponsored by Stryker Trauma and Extremities, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04594993 being conducted?

This trial has 13 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial