A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System
1 other identifier
observational
200
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2026
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2025
CompletedFirst Posted
Study publicly available on registry
August 12, 2025
CompletedStudy Start
First participant enrolled
February 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2038
March 24, 2026
March 1, 2026
4.6 years
August 5, 2025
March 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ankle Osteoarthritis Scale (AOS)
The AOS questionnaire consists of two 9-item subscales: one for pain and one for disability. Each subscale uses a visual analogue scale where patients mark a point on a 100mm horizontal line anchored by "No pain" and "Worst pain imaginable" for pain, or "No difficulty" and "So difficult unable" for disability
Baseline, 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year
Secondary Outcomes (7)
Foot and Ankle Ability Measure (FAAM)
Baseline, 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year
PROMIS Scale v1.2- Global Physical Health Score
Baseline, 6 Month, 1 Year, 2 year, 5 Year, 7 year, 10 Year
PROMIS Scale v1.2- Global Mental Health Score
Baseline, 6 Month, 1 Year, 2 year, 5 Year, 7 year, 10 Year
TAR Satisfaction
6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year
Radiographic Findings
Baseline, 6 months, 1 year, 2 year, 5 year, 7 year, 10 year.
- +2 more secondary outcomes
Study Arms (1)
Incompass™ Total Ankle System
Primary Total Ankle Replacement using the Incompass™ Total Ankle System
Interventions
Eligibility Criteria
No specific methods (such as randomization, blinding or stratification) for assigning participants are used in this protocol. Consecutive participants at each site meeting all of the eligibility criteria will be considered for enrollment in this study.
You may qualify if:
- The participant must be willing and able to sign a written approved informed consent form (ICF) approved by Institutional Review Board (IRB) or Ethics Committee (EC)
- Participants must be males or non-pregnant females aged 21 years or older at the time of surgery;
- Willing and able to comply with the requirements of the clinical investigation plan (CIP), including attend all required study visits.
- The participant must be able to follow instructions and deemed capable of completing clinical investigation questionnaires.
- Considered a candidate for total ankle replacement with the Incompass Total Ankle System in accordance with its legally approved Indication for Use (IFU).
You may not qualify if:
- Participant with an ankle condition, as determined by the investigator, to be an inappropriate candidate for total ankle replacement;
- Participant is currently enrolled in or plans to enroll in any concurrent drug and/or device clinical investigation that, in the opinion of the Investigator, may confound results;
- Any participant that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.44.
- Participants who have participated previously in this clinical trial and who have been withdrawn.
- Participant who is, or will be, inaccessible for follow-up
- Participant is pregnant or intends to become pregnant during the course of the study.
- Participants with a medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the clinical investigation.
- Participants requiring revision total ankle replacement of the ankle being considered for the study;
- Participants with a failed previous ankle surgery (e.g., takedown fusion)
- Participants with any infection at the ankle site or infections at distant sites that could migrate to the ankle, including sepsis and osteomyelitis;
- Participants with compromised vascularity that would inhibit blood supply to the operative site;
- Neuropathic arthropathy of the joint;
- Insufficient bone stock or bone quality that cannot provide adequate support of the device;
- Participants who have documented or suspected sensitivity to the implant materials.
- Participants with inadequate neuromuscular status or those having poor skin coverage around the joint, which would make the procedure unjustifiable
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Illinois Bone and Joint Institute
Morton Grove, Illinois, 60053, United States
Baptist Health Louisville
Louisville, Kentucky, 40207, United States
Slocum Research & Education Foundation
Eugene, Oregon, 97401, United States
MUSC
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rebecca Gibson
Stryker Trauma & Extremities
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2025
First Posted
August 12, 2025
Study Start
February 6, 2026
Primary Completion (Estimated)
September 30, 2030
Study Completion (Estimated)
September 1, 2038
Last Updated
March 24, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share