Unstable Lisfranc Fracture-dislocations of the Midfoot Clinical Trial
Official title:
A Randomized, Prospective Comparison of Stainless Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries
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.
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, the Lisfranc ligaments are damaged. When the Lisfranc ligaments
are disrupted, 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 use of materials that can be absorbed by the human body to fix the Lisfranc ligaments
has only been studied in 1 paper. One such material is the Smart Screw (Bionx, Blue Bell,
Pennsylvania) which is approved by the Food and Drug Administration (F.D.A.) and made of
polylevolactic acid (PLA). Absorbable screws could be ideal for the treatment of Lisfranc
ligament injuries. They can provide a mechanical scaffold to allow for ligament healing.
They are absorbable which eliminates the need for a second surgery to remove a screw. They
can be used for foot injuries where the rate of healing and thus absorption is rapid.
Although, absorbable implants are weaker than metal implants, the absorbable screw can be
protected from breaking by restricting weight bearing after surgery. If the absorbable screw
does break, there is no need to remove the fragments in the foot bones as they are
absorbable.
Comparing the long-term results of fixing the Lisfranc ligaments with either a steel or
absorbable screw is important as there are no studies on the subject to date. There is only
1 published study regarding absorbable screws to fix the Lisfranc ligaments. The purpose of
this study is to compare the outcome of steel and absorbable screw fixation of the Lisfranc
ligaments in foot injuries in two surgeons' practice.
We 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.
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