A Comparison of Stainless Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries
Condition: Unstable Lisfranc Fracture-dislocations of the Midfoot
MeSH terms: Joint Dislocations; Fracture Dislocation; Foot Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Steel screw fixation of Lisfranc fracture-dislocation.; Absorbable screw fixation of Lisfranc fracture-dislocations.
Intervention type(s): Procedure; Procedure
Intervention description(s): Stainless steel screw fixation of unstable Lisfranc fracture-dislocations of the midfoot.; Bioabsorbable (poly-levo-lactic acid) screw fixation of unstable Lisfranc fracture-dislocations of the midfoot.
Other intervention name(s): Steel screw; Smart Screw
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Unstable; Lisfranc; fracture; dislocation; midfoot