Actively Recruiting
A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System
Led by Stryker Trauma and Extremities · Updated on 2026-03-24
200
Participants Needed
4
Research Sites
413 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the Incompass™ Total Ankle System in people who have ankle replacement surgery. The study aims to measure improvements in quality of life and pain through patient-reported information and routine medical imaging such as X-rays and CT scans. This system has been approved by the Food and Drug Administration and is already used in ankle replacement surgeries, so no part of the study is experimental. The study plans to enroll about 200 participants over three years at up to ten locations. Participants will receive a total ankle replacement surgery using the Incompass™ Total Ankle System, following the surgeon's usual care practices. The study will include reviewing medical images taken as part of routine care and any additional X-rays during the study period to assess the device's performance. Participants will be followed for up to 10 years with scheduled assessments at baseline, 6 months, 1, 2, 5, 7, and 10 years after surgery. Assessments include the Ankle Osteoarthritis Scale, Foot and Ankle Ability Measure, PROMIS Global Health questionnaires, TAR Satisfaction surveys, and radiographic evaluations. Safety will be monitored by tracking adverse events, reoperations, and implant survivorship. Participants will attend all required study visits and complete questionnaires during these times.
CONDITIONS
Brief Title
A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to sign an approved informed consent form
- Males or non-pregnant females aged 21 years or older at surgery
- Willing and able to comply with study visit requirements
- Able to follow instructions and complete study questionnaires
- Considered a candidate for total ankle replacement with the Incompass Total Ankle System as per its approved use
You will not qualify if you...
- Ankle condition making total ankle replacement inappropriate
- Currently enrolled in or planning other drug/device clinical investigations that may affect results
- Meets definition of a vulnerable subject per ISO 14155 Section 3.44
- Previously participated in this trial and withdrawn
- Inaccessible for follow-up
- Pregnant or intending pregnancy during the study
- Medical or physical conditions precluding safe participation
- Requires revision total ankle replacement on the study ankle
- Failed previous ankle surgery (e.g., takedown fusion)
- Infection at the ankle or other sites that could spread to the ankle
- Compromised blood supply to the operative site
- Neuropathic arthropathy of the joint
- Insufficient bone stock or poor bone quality for device support
- Documented or suspected sensitivity to implant materials
- Inadequate neuromuscular status or poor skin coverage around the joint
- Routinely placing excessive loads on the ankle due to activity or weight
- Mental or neuromuscular disorders increasing risk in postoperative care
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants undergo primary total ankle replacement surgery using the Incompass™ Total Ankle System.
1 visit (surgery day)
Duration - Up to 10 years
Participants are followed with imaging and assessments to monitor safety, performance, and satisfaction after surgery.
Visits at Baseline, 6 months, 1 year, 2 years, 5 years, 7 years, and 10 years
Trial Site Locations
Total: 4 locations
1
Illinois Bone and Joint Institute
Morton Grove, Illinois, United States, 60053
Actively Recruiting
2
Baptist Health Louisville
Louisville, Kentucky, United States, 40207
Actively Recruiting
3
Slocum Research & Education Foundation
Eugene, Oregon, United States, 97401
Actively Recruiting
4
MUSC
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
C
Caryn Thompson
R
Rebecca Gibson
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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