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

Who can take part

• 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)
• Participants must be males or non-pregnant females aged 21 years or older at the time of surgery
• Willing and able to comply with the requirements of the clinical investigation plan (CIP), including attend all required study visits
• The participant must be able to follow instructions and deemed capable of completing clinical investigation questionnaires
• Considered a candidate for total ankle replacement with the Incompass Total Ankle System in accordance with its legally approved Indication for Use (IFU)

Who cannot take part

• 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
• Participants who have participated previously in this clinical trial and who have been withdrawn
• Participants with a failed previous ankle surgery (e.g., takedown fusion)
• Participants who have documented or suspected sensitivity to the implant materials
• Participant with an ankle condition, as determined by the investigator, to be an inappropriate candidate for total ankle replacement
• Participants with a medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the clinical investigation
• Participants with any infection at the ankle site or infections at distant sites that could migrate to the ankle, including sepsis and osteomyelitis
• Any mental or neuromuscular disorder that would create an unacceptable risk of failure or complications in postoperative care
• Any participant that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.44
• Participant who is, or will be, inaccessible for follow-up
• Participant is pregnant or intends to become pregnant during the course of the study
• Participants requiring revision total ankle replacement of the ankle being considered for the study
• Participants with compromised vascularity that would inhibit blood supply to the operative site
• Neuropathic arthropathy of the joint
• Insufficient bone stock or bone quality that cannot provide adequate support of the device
• Participants with inadequate neuromuscular status or those having poor skin coverage around the joint, which would make the procedure unjustifiable
• Participant who routinely place excessive loads on their ankle as caused by activity and/or patient weight, per investigator discretion; or