Follow-up of the Incompass Total Ankle System after total ankle replacement surgery.

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

The Incompass Total Ankle System will be followed to see if it is safe and helps reduce pain and improve quality of life in adults having total ankle replacement.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Stryker Trauma and Extremities (industry)
• Locations: 4 sites (Morton Grove, Illinois and 3 other locations)
• Trial ID: NCT07118501 on ClinicalTrials.gov

What this trial studies

This is a prospective, post-market, observational follow-up that plans to enroll about 200 adults treated with the FDA-cleared Incompass Total Ankle System at up to ten U.S. centers over a three-year enrollment period. Participants will receive the surgeon's standard of care and undergo routine imaging (x-rays and/or CT) with outcomes tracked using patient-reported measures (AOS, PROMIS Global Health, FAAM, TAR Satisfaction) and radiographic assessments. The primary endpoint is improvement in the Ankle Osteoarthritis Scale (AOS) at 24 months after the index surgery, with secondary endpoints that include safety outcomes (adverse events, reoperation, survivorship) and implant performance on imaging. No implant procedure is experimental since the device is FDA-cleared, and data are collected from routine care visits and any additional clinical imaging obtained during follow-up.

Who should consider this trial

Good fit: Adults aged 21 and older who are appropriate candidates for total ankle replacement with the Incompass system, can give informed consent, and can complete required follow-up visits and questionnaires.

Not a fit: Patients judged inappropriate for total ankle replacement, pregnant individuals, or those enrolled in conflicting investigational drug/device trials may not receive benefit from participation.

Why it matters

Potential benefit: If successful, the study could confirm the device's safety and show measurable reductions in pain and improvements in function and quality of life at two years.

How similar studies have performed: Other published clinical series and post-market data for total ankle replacement devices have demonstrated improvements in pain and function, and the Incompass device is FDA-cleared and in routine clinical use.

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.

Where this trial is running

Morton Grove, Illinois and 3 other locations

• Illinois Bone and Joint Institute — Morton Grove, Illinois, United States (RECRUITING)
• Baptist Health Louisville — Louisville, Kentucky, United States (RECRUITING)
• Slocum Research & Education Foundation — Eugene, Oregon, United States (RECRUITING)
• MUSC — Charleston, South Carolina, United States (RECRUITING)

Study contacts

• Study coordinator: Caryn Thompson

Conditions: Post Traumatic Arthritis, Osteoarthritis, Total Ankle Replacement, Total Ankle Prosthesis