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NCT07118501 · ClinicalTrials.gov registry record
A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System
A clinical trial of Osteoarthritis and Post Traumatic Arthritis, sponsored by Stryker Trauma and Extremities.
- Recruiting
- Registry status
- 200
- Enrollment target
- 4
- Study locations
NCT07118501: Recruiting study of Osteoarthritis and Post Traumatic Arthritis, sponsored by Stryker Trauma and Extremities.
NCT07118501 is a study of Osteoarthritis and Post Traumatic Arthritis that is actively recruiting participants, run by Stryker Trauma and Extremities. The registered enrollment target is 200 participants, below the 816-participant average among 135 other Osteoarthritis trials with a reported enrollment target (75% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07118501, a study of Osteoarthritis and Post Traumatic Arthritis, is actively recruiting participants, sponsored by Stryker Trauma and Extremities.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
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
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 |
What NCT07118501 shows while recruiting
NCT07118501 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 816-participant average among 135 other Osteoarthritis trials with a reported enrollment target (75% lower).
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.
NCT07118501 reports a single indexed study location in Illinois, Kentucky, Oregon.
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.
What interventions are being tested in trial NCT07118501?
The interventions under investigation include: Total Ankle Replacement (DEVICE).
Who is sponsoring clinical trial NCT07118501?
This trial is sponsored by Stryker Trauma and Extremities, which has 30 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Osteoarthritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07118501's enrollment target sits among peer trials
200 57th of 135 higher than 75 of 135 other Osteoarthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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