A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorStryker Trauma and Extremities
About this trial
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
Qualifiers
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.
Disqualifiers
Participant with an ankle condition, as determined by the investigator, to be an inappropriate candidate for total ankle replacement;
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;
Any participant that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.44.
Participants who have participated previously in this clinical trial and who have been withdrawn.
Trial design
Treatments tested in this trial
- Total Ankle Replacement
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov