NCT07118501 A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System
| NCT ID | NCT07118501 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stryker Trauma and Extremities |
| Condition | Post Traumatic Arthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-02-06 |
| Primary Completion | 2030-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2026-02-06 with a primary completion date of 2030-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Rebecca Gibson
STUDY DIRECTOR
Stryker Trauma & Extremities
Frequently Asked Questions
Who can join the NCT07118501 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Post Traumatic Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07118501 currently recruiting?
Yes, NCT07118501 is actively recruiting participants. Contact the research team at caryn.thompson@stryker.com for enrollment information.
Where is the NCT07118501 trial being conducted?
This trial is being conducted at Morton Grove, United States, Louisville, United States, Eugene, United States, Charleston, United States.
Who is sponsoring the NCT07118501 clinical trial?
NCT07118501 is sponsored by Stryker Trauma and Extremities. The principal investigator is Rebecca Gibson at Stryker Trauma & Extremities. The trial plans to enroll 200 participants.