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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 Participants who have participated previously in this clinical trial and who have been withdrawn.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 it's running

• Illinois Bone and Joint Institute
  Morton Grove, Illinois, United States Recruiting
• South Bend Orthopedics
  South Bend, Indiana, 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: Bridget Tiernan
• Email: Bridget.Tiernan@stryker.com
• Phone: 983-277-1281

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Observational study on total wrist replacement outcomes with KinematX implant

  This study is testing how well the KinematX wrist replacement helps people regain movement and strength in their wrist after surgery.

  Recruiting at 4 sites Extremity Medical · Loma Linda, California and 3 other locations · NCT05719935

• Autologous adipose-derived stem cell injections for knee osteoarthritis

  We’re testing whether injecting a patient’s own fat-derived stem cells into the knee can help people with knee OA feel less pain and move better, compared with a standard hyaluronic acid treatment.

  Recruiting at 3 sites Yonsei University · Incheon and 2 other locations · NCT07901790

• Early wear of a Vitamin E-infused liner in a dual-mobility hip replacement

  This study tests whether a Vitamin E-infused liner in a dual-mobility hip implant wears as little as a conventional liner over two years in adults needing hip replacement.

  Recruiting Phase 4 Uppsala University · Uppsala, Uppsala County · NCT07863557

• Preoperative Music to Ease Anxiety Before Hip or Knee Replacement

  Patients awaiting hip or knee replacement listen to their own music through noise‑canceling headphones to see if it lowers preoperative anxiety.

  Recruiting Columbia University · New York, New York · NCT07845695

• Weight-bearing dangling exercises vs VMOb NMES for knee osteoarthritis

  This study tests whether weighted dangling exercises or VMOb muscle NMES help people with knee osteoarthritis.

  Recruiting University of Lahore · Lahore, Punjab Province · NCT07701174

• Post-op prednisone vs standard steroid regimen after knee or hip replacement

  This study tests a 5-day oral prednisone course after knee or hip replacement to see if pain, swelling, and glucose control are better or different than the usual intraoperative steroid approach.

  Recruiting Phase 4 Columbia University · New York, New York · NCT07630896

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.