Osteoarthritis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who are willing and able to sign an approved consent form before taking part
- People who are male or non-pregnant female, aged 21 years or older at the time of surgery
- People who are willing and able to attend all required study visits and follow the study plan
- People who are able to follow instructions and complete study questionnaires
- People who a doctor has determined are suitable candidates for total ankle replacement surgery using the Incompass Total Ankle System, in line with its approved intended use
Who may not be able to join:
- People whose ankle condition the treating doctor considers unsuitable for total ankle replacement surgery
- People who are currently enrolled in, or plan to join, another drug or device clinical trial that the investigator believes could affect the results
- People who meet the definition of a "vulnerable subject" under international clinical trial standards (confirm with trial site)
- People who were previously enrolled in this same trial but withdrew from it
- People who would not be available for follow-up appointments after surgery
- People who are pregnant or plan to become pregnant during the study period
- People who have a medical or physical condition that the investigator believes would make participation unsafe
- People who need a revision (repeat) ankle replacement surgery on the ankle being considered for the study
- People who have had a previous ankle surgery that was unsuccessful, such as a fusion reversal procedure
- People who have an active infection at the ankle or elsewhere in the body that could spread to the ankle, including bone infections or widespread infection in the blood
- People who have poor blood supply to the area where surgery would take place
- People who have nerve-related joint damage (neuropathic arthropathy) in the ankle (confirm with trial site)
- People whose bones are not strong or substantial enough to properly support the implant device
- People who have a known or suspected allergy or sensitivity to the materials used in the implant
- People who have poor muscle or nerve function, or poor skin condition around the ankle joint, that would make the surgery unsuitable
- People whose ankle is regularly subjected to excessive stress due to their level of physical activity or body weight, as judged by the treating doctor
- People who have a mental health or neuromuscular condition that would create an unacceptable risk of complications or poor outcomes after surgery
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Rebecca Gibson, Stryker Trauma & Extremities
Phone: 704-891-6540
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Ankle Osteoarthritis Scale (AOS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.