A Comparison of Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries (NCT00689962) | Clinical Trial Compass
CompletedPhase 4
A Comparison of Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries
United States50 participantsStarted 2008-07
Plain-language summary
I hypothesize that absorbable screw fixation of the foot's Lisfranc ligaments does not yield significant differences in postoperative foot stability, ligament function, and symptoms when compared to steel screw fixation. In addition, absorbable screw fixation of the Lisfranc ligaments offers the advantage that a second surgical procedure to remove the screw is not necessary.
Who can participate
Age range
18 Years – 75 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
. Subjects will be adults of any gender or race.
. Subjects will be adults between 18 and 75 years of age.
. The underlying diagnosis will be a Lisfranc foot injury.
. The indication for fixing the Lisfranc ligaments is abnormal separation of the middle part of the foot from each other.
. Subjects will have received either a steel or absorbable screw to fix the Lisfranc ligaments.
Exclusion criteria
. Subjects may not have any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures.
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.
. Subjects may not have a history of known alcohol, analgesic, or narcotic substance abuse within 12 months prior to pretreatment.
. Subjects may not have a history of severe psychiatric illness such as depression or psychosis that may influence the results of administered outcome questionnaires.
. Subjects may not be pregnant.
. Subjects may be excluded from this study for any reason that may pose unnecessary risk or confounding of data, in the judgment of the investigator. This includes the 4 above points.
. Subjects must not have intact or normal Lisfranc ligaments in the foot.
. Subjects may not have a history of deep Lisfranc joint infection.