A Comparison of Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries

Completed · Phase 4

Conditions studied: Joint Instability

In brief

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.

Key facts

Study ID

NCT00689962

Run by

Rothman Institute Orthopaedics

People needed

50

Starts

2008-07-01

Expected to finish

2016-07-01

Last updated by the study team

2017-01-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Subjects may not have any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures.
• 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.

Where it is running

• Riddle Memorial Hospital — Media, Pennsylvania, United States
• Nazareth Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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