Evaluation of Trinity Evolution in Patients Undergoing Foot and Ankle Fusion (NCT00988338) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Trinity Evolution in Patients Undergoing Foot and Ankle Fusion
United States106 participantsStarted 2009-09
Plain-language summary
The purpose of this study is to utilize Trinity Evolution as a graft source in foot/ankle fusions and to follow the subjects to measure the clinical outcomes and fusion rate. The hypothesis of the study is that Trinity Evolution will result in fusion rates and clinical outcomes similar to those obtained from autograft and other routinely used allograft materials; these include: fusion, improvement in pain, improvement in function, and absence of adverse events related to the use of the graft source.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Foot and/or ankle pathology requiring fusion using open surgical technique with supplemental bone graft/substitute requiring one of the following procedures:
* Ankle joint fusion
* Subtalar fusion
* Calcaneocuboid fusion
* Talonavicular fusion
* Double fusions (talonavicular and calcaneocuboid joints)
* Triple fusions (subtalar, talonavicular, and calcaneocuboid joints)
* At least 18 years of age
* Willing and able to comply with the requirements of the protocol including follow-up requirements
* Willing and able to sign a study-specific informed consent.
Exclusion Criteria:
* Use of any other bone graft or bone graft substitute in addition to or in place of Trinity Evolution at the time of surgery
* Use of adjunctive post-operative stimulation
* Active local or systemic infection
* Currently pregnant or considering becoming pregnant during the follow-up period
* Active malignancy or having been on chemotherapy of any kind for a malignancy in the past 1 year
* Immunosuppressive therapy of any kind within the past 1 year
* Has a known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.