Post Traumatic ArthritisNCT07118501
A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System
An observational study of Post Traumatic Arthritis and Osteoarthritis, run by Stryker Trauma and Extremities at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Post Traumatic Arthritis, Osteoarthritis, Total Ankle Replacement
- What is being tested?
- Total Ankle Replacement
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Feb 2026to 1 Sep 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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 join
- 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.
- Participant who is, or will be, inaccessible for follow-up
- Participant is pregnant or intends to become pregnant during the course of the study.
Show all 17Show fewer
- Participants with a medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the clinical investigation.
- Participants requiring revision total ankle replacement of the ankle being considered for the study;
- Participants with a failed previous ankle surgery (e.g., takedown fusion)
- Participants with any infection at the ankle site or infections at distant sites that could migrate to the ankle, including sepsis and osteomyelitis;
- 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 who have documented or suspected sensitivity to the implant materials.
- 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
- Any mental or neuromuscular disorder that would create an unacceptable risk of failure or complications in postoperative care.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Caryn Thompson contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
MUSC
Charleston, South Carolina, 29425
Sierra Tufts, 619-407-0820, tuftssi@musc.edu
Hana Hashioka, (843) 792-8169, hashioka@musc.edu
- Recruiting
Slocum Research & Education Foundation
Eugene, Oregon, 97401
Hannah College, hannah.college@slocumfoundation.org
Lyle Jackson, MD
- Recruiting
Baptist Health Louisville
Louisville, Kentucky, 40207
Karin Cryan, BSN RN CCRP, Karin.cryan@bhsi.com
John S Lewis, Jr, MD
- Recruiting
Illinois Bone and Joint Institute
Morton Grove, Illinois, 60053
Vanessa Diaz, 847-783-1652, vidaz@ibji.com
Daisy Zarco, dzarco@ibji.com
- Recruiting
South Bend Orthopedics
South Bend, Indiana, 46635
Derek Yocum, PhD, 574-247-9441 ext. 5199, dyocum@sbortho.com
Thomas Bemenderfer, MD
About this study
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.
Read the detailed description
It is anticipated that a total of 200 subjects will be enrolled at up to ten sites over a three year enrollment period. The study has been designed to follow the surgeon's standard of care for subjects treated with a total ankle replacement including imaging (x-rays and or CT scans).
The primary endpoint of this study is the 24-month total Ankle Osteoarthritis Scale (AOS) score improvement after index surgery (or Initial Assessment). Secondary endpoints include safety (adverse events, reoperation, and survivorship) as well as performance measures (radiographic assessments, PROMIS Global Health questionnaire, Foot and Ankle Ability Measure [FAAM] and Total Ankle Replacement [TAR] Satisfaction questionnaires).
- Being tested
- Total Ankle Replacement
- Keywords
- Total Ankle Replacement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Ankle ReplacementDevice
Incompass™ Total Ankle System
| Study group | Role | What they receive |
|---|---|---|
| Incompass™ Total Ankle System | Primary Total Ankle Replacement using the Incompass™ Total Ankle System Receives: Device: Total Ankle Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year
Secondary outcomes (7)
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.
Measured: Baseline, 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year
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.
Measured: Baseline, 6 Month, 1 Year, 2 year, 5 Year, 7 year, 10 Year
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.
Measured: Baseline, 6 Month, 1 Year, 2 year, 5 Year, 7 year, 10 Year
TAR Satisfaction
Patient satisfaction with the Incompass™ Total Ankle System post-operatively is assessed utilizing a four-point scale: excellent, good, fair and poor.
Measured: 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year
Radiographic Findings
Radiographic assessment for component loosening and/or subsidence, any osteolysis and/or cyst formation early and through the lifetime of the implant.
Measured: Baseline, 6 months, 1 year, 2 year, 5 year, 7 year, 10 year.
Safety - Adverse Event
The incidence of device-related Adverse Events by 10 years, as collected and reported by the Investigator
Measured: Baseline to 10 years postoperative
Safety - Survivorship
The survivorship rate by 10 years, as defined with a Kaplan-Meier survivorship analysis.
Measured: Baseline to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start6 Feb 2026
- Primary completion30 Sep 2030 (estimated)
- Study completion1 Sep 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic ArthritisStudies of the same condition, open and under way.
- More trials run by Stryker Trauma and ExtremitiesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Gibson, Study director, Stryker Trauma & Extremities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118501
- Sponsor's protocol ID
- FA-02-2024
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System
- ClinicalTrials.gov ID
- NCT07118501
- Acronym / sponsor ID
- FA-02-2024
- Keywords
- Total Ankle Replacement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 1 Sep 2038 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is anticipated that a total of 200 subjects will be enrolled at up to ten sites over a three year enrollment period. The study has been designed to follow the surgeon's standard of care for subjects treated with a total ankle replacement including imaging (x-rays and or CT scans).
The primary endpoint of this study is the 24-month total Ankle Osteoarthritis Scale (AOS) score improvement after index surgery (or Initial Assessment). Secondary endpoints include safety (adverse events, reoperation, and survivorship) as well as performance measures (radiographic assessments, PROMIS Global Health questionnaire, Foot and Ankle Ability Measure [FAAM] and Total Ankle Replacement [TAR] Satisfaction questionnaires).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Incompass™ Total Ankle System | – | Device: Total Ankle ReplacementPrimary Total Ankle Replacement using the Incompass™ Total Ankle System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (17 listed)
- 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.
- Participant who is, or will be, inaccessible for follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Ankle ReplacementIncompass™ Total Ankle System | Device | Incompass™ Total Ankle System |
Primary outcome
Ankle Osteoarthritis Scale (AOS)
Time frame: Baseline, 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year
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
7 secondary outcomes
Foot and Ankle Ability Measure (FAAM)
Time frame: Baseline, 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year
PROMIS Scale v1.2- Global Physical Health Score
Time frame: Baseline, 6 Month, 1 Year, 2 year, 5 Year, 7 year, 10 Year
PROMIS Scale v1.2- Global Mental Health Score
Time frame: Baseline, 6 Month, 1 Year, 2 year, 5 Year, 7 year, 10 Year
TAR Satisfaction
Time frame: 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year
Radiographic Findings
Time frame: Baseline, 6 months, 1 year, 2 year, 5 year, 7 year, 10 year.
Safety - Adverse Event
Time frame: Baseline to 10 years postoperative
Safety - Survivorship
Time frame: Baseline to 10 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caryn Thompson contact
Rebecca Gibson study director
Stryker Trauma & Extremities
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Arthritis and Osteoarthritis, run by Stryker Trauma and Extremities at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bridget Tiernan (983-277-1281, Bridget.Tiernan@stryker.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle Osteoarthritis Scale (AOS) (time frame: Baseline, 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.