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
This trial does not accept healthy volunteersQualifiers
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Participants who have participated previously in this clinical trial and who have been withdrawn.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 population
No specific methods (such as randomization, blinding or stratification) for assigning participants are used in this protocol. Consecutive participants at each site meeting all of the eligibility criteria will be considered for enrollment in this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Total Ankle Replacement
DeviceIncompass™ Total Ankle System
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Incompass™ Total Ankle System1 intervention
Trial outcomes
Primary outcomes
1
Ankle Osteoarthritis Scale (AOS)
The AOS questionnaire consists of two 9-item subscales: one for pain and one for disability. Each subscale uses a visual analogue scale where patients mark a point on a 100mm horizontal line anchored by "No pain" and "Worst pain imaginable" for pain, or "No difficulty" and "So difficult unable" for disability
Time frame
Baseline, 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 YearSecondary outcomes
1
Foot and Ankle Ability Measure (FAAM)
The FAAM has 29 questions and two components that are scored independently: an Activities of Daily Living (ADL) subscale and a Sports subscale. Each subscale is scored from 0 to 100 points, with higher scores representing better function.
Time frame
Baseline, 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year2
PROMIS Scale v1.2- Global Physical Health Score
The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score." The average "TScore" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Time frame
Baseline, 6 Month, 1 Year, 2 year, 5 Year, 7 year, 10 Year3
PROMIS Scale v1.2- Global Mental Health Score
The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score." The average "TScore" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Time frame
Baseline, 6 Month, 1 Year, 2 year, 5 Year, 7 year, 10 Year4
TAR Satisfaction
Patient satisfaction with the Incompass™ Total Ankle System post-operatively is assessed utilizing a four-point scale: excellent, good, fair and poor.
Time frame
6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 YearSponsors and contacts
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Source ClinicalTrials.gov