A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System

Part of paid clinical trials in Morton Grove, Illinois.

Sponsor
Stryker Trauma and Extremities
Study ID
NCT07118501
Status
Recruiting
Apply to this trial

Conditions

  • Osteoarthritis
  • Post Traumatic Arthritis
  • Total Ankle Prosthesis
  • Total Ankle Replacement

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Total Ankle Replacement — DEVICE
    Incompass™ Total Ankle System

Study Details

The goal of this study is to demonstrate the safety and performance of the Incompass™ Total Ankle System after surgery over the standard follow-up period. The study will measure improvements in patient-reported information related to quality of life and pain following surgery. In order to do this, medical imaging (i.e. X-Rays, CT scans) which have been taken as part of routine care, will be reviewed. Any additional X-Rays conducted during the period of the research will also be reviewed. The Incompass™ Total Ankle System has been cleared by the Food and Drug Administration (FDA). The products are already in use routinely in ankle replacement surgeries. No part of this study is experimental.

Key Dates

Start date
Feb 6, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2030
Completion
Sep 1, 2038

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Incompass™ Total Ankle System
    Primary Total Ankle Replacement using the Incompass™ Total Ankle System

Primary Outcome Measure

Ankle Osteoarthritis Scale (AOS) [ Time Frame: Baseline, 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Illinois Bone and Joint InstituteMorton GroveIllinois60053
Vanessa Diaz
[email protected]
847-783-1652
Daisy Zarco
[email protected]
Brian Weatherford, MD (PRINCIPAL_INVESTIGATOR)
Baptist Health LouisvilleLouisvilleKentucky40207
Karin Cryan, BSN RN CCRP
[email protected]
John S Lewis, Jr, MD (PRINCIPAL_INVESTIGATOR)
Slocum Research & Education FoundationEugeneOregon97401
Hannah College
[email protected]
Lyle Jackson, MD (PRINCIPAL_INVESTIGATOR)
MUSCCharlestonSouth Carolina29425
Sierra Tufts
[email protected]
619-407-0820
Hana Hashioka
[email protected]
(843) 792-8169
Christopher Gross, MD (PRINCIPAL_INVESTIGATOR)
Daniel Scott, MD (SUB_INVESTIGATOR)

Find similar trials in Morton Grove, IL

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
Illinois Bone and Joint Institute· Morton Grove, ILBaptist Health Louisville· Louisville, KYSlocum Research & Education Foundation· Eugene, ORMUSC· Charleston, SC

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