Ireland
--:--IST
Recruiting Observational

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

NCT07118501 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2026-02-06
Last updated
2026-08-24

Condition(s) studied

Post Traumatic ArthritisOsteoarthritisTotal Ankle ReplacementTotal Ankle Prosthesis

Investigational drug(s) / intervention(s)

Total Ankle Replacement

Total Ankle Replacement: Incompass™ Total Ankle System

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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. 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) 2. Participants must be males or non-pregnant females aged 21 years or older at the time of surgery; 3. Willing and able to comply with the requirements of the clinical investigation plan (CIP), including attend all required study visits. 4. The participant must be able to follow instructions and deemed capable of completing clinical investigation questionnaires. 5. Considered a candidate for total ankle replacement with the Incompass Total Ankle System in accordance with its legally approved Indication for Use (IFU). Exclusion Criteria: 1. Participant with an ankle condition, as determined by the investigator, to be an inappropriate candidate for total ankle replacement; 2. 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; 3. Any participant that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.44. 4. Participants who have participated previously in this clinical trial and who have been withdrawn. 5. Participant who is, or will be, inaccessible for follow-up 6. Participant is pregnant or intends to become pregnant during the course of the study. 7. Participants with a medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the clinical investigation. 8. Participants requiring revision total ankle replacement of the ankle being considered for the study; 9. Participants with a failed previous ankle surgery (e.g., takedown fusion) 10. Participants with any infection at the ankle site or infections at distant sites that could migrate to the ankle, including sepsis and osteomyelitis; 11. Participants with compromised vascularity that would inhibit blood supply to the operative site; 12. Neuropathic arthropathy of the joint; 13. Insufficient bone stock or bone quality that cannot provide adequate support of the device; 14. Participants who have documented or suspected sensitivity to the implant materials. 15. Participants with inadequate neuromuscular status or those having poor skin coverage around the joint, which would make the procedure unjustifiable 16. Participant who routinely place excessive loads on their ankle as caused by activity and/or patient weight, per investigator discretion; or 17. Any mental or neuromuscular disorder that would create an unacceptable risk of failure or complications in postoperative care.

Primary outcome measure(s)

  • Ankle Osteoarthritis Scale (AOS) — Baseline, 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year
    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

Trial sites (5)

FacilityCityRegionStatus
Illinois Bone and Joint Institute Morton Grove Illinois Recruiting
South Bend Orthopedics South Bend Indiana Recruiting
Baptist Health Louisville Louisville Kentucky Recruiting
Slocum Research & Education Foundation Eugene Oregon Recruiting
MUSC Charleston South Carolina Recruiting

More Stryker Trauma and Extremities trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07118501 on ClinicalTrials.gov ↗ ← All trials in the USA