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

Completed · Phase 4

Conditions studied: Unstable Lisfranc Fracture-dislocations of the Midfoot

In brief

The Lisfranc ligaments are a group of ligaments that connect the bones of the middle portion of the foot to each other. The Lisfranc ligaments allow for a normal and stable range of motion and shape to the foot. In certain foot fractures where the Lisfranc ligaments are damaged, the constraint and stability it had given to the middle of the foot is lost. Attempted activity at the foot will result in pain and abnormal motion. If injury to the Lisfranc ligaments is left untreated, the eventual end result is foot arthritis and deformity. The current standard orthopaedic treatment of foot fractures with Lisfranc ligament injuries is surgery. The foot fractures are fixed with metal screws. The Lisfranc ligaments are fixed by compressing the space between the middle bones of the foot with steel screws. These screws allow for ligament healing. As the ligaments heal, the patient should not resume activity with the fixed foot too soon as the screw may break. Upon breakage, the ligament repair may fail and the screw is now difficult to surgically remove. Regardless of breakage, a second surgical procedure is often recommended to remove the steel screw 6 months after foot surgery. This allows for a complete return of normal foot range of motion, but at the cost of a second surgical procedure. The investigators hypothesize that absorbable screw fixation of the 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

NCT00985023

Run by

Rothman Institute Orthopaedics

People needed

50

Starts

2008-08-01

Expected to finish

2016-08-01

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.
• 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 must not have intact or normal Lisfranc ligaments in the foot.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.