Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System
NCT07118501 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE Total Ankle Replacement
Study Locations (4)
Illinois
- Illinois Bone and Joint Institute — Morton Grove
Kentucky
- Baptist Health Louisville — Louisville
Oregon
- Slocum Research & Education Foundation — Eugene
South Carolina
- MUSC — Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2026-02-06 |
| Est. Completion | 2038-09-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07118501
The ClinicalTrials.gov registry entry for NCT07118501 describes a study currently listed as 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 4 conditions, with Osteoarthritis appearing as the primary indexed condition, and to 1 intervention — of which Total Ankle Replacement 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: NCT07118501 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Illinois, Kentucky, 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 NCT07118501 about?
NCT07118501 is a clinical study titled "A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System". 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, m...
What is the current status of trial NCT07118501?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2026-02-06. Estimated completion is 2038-09-01.
What conditions does trial NCT07118501 study?
This clinical trial studies the following conditions: Osteoarthritis, Post Traumatic Arthritis, Total Ankle Replacement, Total Ankle Prosthesis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07118501?
The interventions under investigation include: Total Ankle Replacement (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07118501?
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 NCT07118501 being conducted?
This trial has 4 study locations across Illinois, Kentucky, Oregon, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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