No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 and older
Sex
Any
Study type
Observational
Participants needed
200 (estimated)
Sponsor
Stryker Trauma and Extremities · Industry
Who this trial is looking for
This trial is looking for adults who are having ankle replacement surgery. Participants will share their experience with pain and quality of life after the surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I am 21 years or older
I am willing to sign the consent form
I can follow instructions for surveys
I am considered a candidate for total ankle replacement
I will attend all required study visits
You may not be able to join if
I have an ankle condition that makes me unsuitable for surgery
I am currently enrolled in another clinical trial
I am pregnant or planning to become pregnant
I have had a failed previous ankle surgery
I have an infection at the ankle site
I have poor blood supply to the ankle
I have a mental disorder that could complicate care
I have documented sensitivity to the implant materials
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 review…
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.
Trial Locations
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Facility
City
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Status
Eligibility Criteria
Inclusion Criteria:
1. 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)
2. Participants must be males or non-pregnant females aged 21 years or older at the time of surgery;
3. Willin…
Inclusion Criteria:
1. 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)
2. Participants must be males or non-pregnant females aged 21 years or older at the time of surgery;
3. Willing and able to comply with the requirements of the clinical investigation plan (CIP), including attend all required study visits.
4. The participant must be able to follow instructions and deemed capable of completing clinical investigation questionnaires.
5. Considered a candidate for total ankle replacement with the Incompass Total Ankle System in accordance with its legally approved Indication for Use (IFU).
Exclusion Criteria:
1. Participant with an ankle condition, as determined by the investigator, to be an inappropriate candidate for total ankle replacement;
2. 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;
3. Any participant that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.44.
4. Participants who have participated previously in this clinical trial and who have been withdrawn.
5. Participant who is, or will be, inaccessible for follow-up
6. Participant is pregnant or intends to become pregnant during the course of the study.
7. Participants with a medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the clinical investigation.
8. Participants requiring revision total ankle replacement of the ankle being considered for the study;
9. Participants with a failed previous ankle surgery (e.g., takedown fusion)
10. Participants with any infection at the ankle site or infections at distant sites that could migrate to the ankle, including sepsis and osteomyelitis;
11. Participants with compromised vascularity that would inhibit blood supply to the operative site;
12. Neuropathic arthropathy of the joint;
13. Insufficient bone stock or bone quality that cannot provide adequate support of the device;
14. Participants who have documented or suspected sensitivity to the implant materials.
15. Participants with inadequate neuromuscular status or those having poor skin coverage around the joint, which would make the procedure unjustifiable
16. Participant who routinely place excessive loads on their ankle as caused by activity and/or patient weight, per investigator discretion; or
17. Any mental or neuromuscular disorder that would create an unacceptable risk of failure or complications in postoperative care.
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