A Comparison of Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries
Condition: Joint Instability
MeSH terms: Joint Instability; Foot Injuries
Study type: Interventional
Phase: Phase 4

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.
    

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.

      When the Lisfranc ligaments are disrupted, the 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 Lisfranc ligament injuries is surgery. 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. A
      second surgical procedure is often recommended to remove the screw 6 months after surgery.
      This allows for a complete return of normal foot range of motion, but at the cost of a second
      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.

      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 one surgeon's (J.A.) practice at Thomas Jefferson University
      Hospital, Riddle Memorial Hospital, and Nazareth Hospital.

      This study will be conducted in a prospective manner. This study does not focus on
      experimental procedures or components, but rather involves the accepted management of a
      select population of patients.

      This study will be performed in a randomized, prospective manner involving 2 groups of
      patients (steel vs. bioabsorbable screw populations) from 3 different hospitals. Power
      analysis has been conducted to ensure an adequate patient population size.

      The risks to patients will be minimal. The standard risks of fixing the Lisfranc ligaments
      include bleeding, infection, nerve injury, recurrent foot instability, and the dangers of
      administering anesthesia.

      Study Groups Chosen patients for this study will be randomly assigned to one of two groups.
      Group A will consist of patients that receive the steel screw. Group B will contain the
      patients that receive the absorbable screw. Postoperative activity restrictions and
      rehabilitation will be kept the same between the two groups.

      Routine protocols for care of foot fracture patients will be utilized regarding infection,
      wound care, pain control, and weightbearing restrictions. The involved foot will be placed in
      a non-weight-bearing splint that patients are requested to avoid handling until it is removed
      by the PI upon the first postoperative visit.

      Patients who have their injury fixed using steel screws, need a second surgery in 6 months
      for removal of the screw. This is the standard textbook treatment and is not a revision
      surgery. Patients who will receive absorbable screw, wont need this surgery. This will be
      discussed with the patient at the time of the approach for recruitment.

      Outcome evaluation The PI will monitor and follow the patients during and after surgery. Data
      collection will include the details of the surgery, intraoperative and postoperative course
      including complications if applicable, and number of revision surgeries performed should they
      occur. These patients received postoperative follow-up at 2 weeks, 6 weeks, 3 months, 6
      months, 1 year, 2 years, and 3 years. Both groups of patients are prohibited from bearing
      weight on the affected foot for six weeks. Patients will be instructed to gradually increase
      weight-bearing starting at six weeks.

      Postoperative satisfaction and function which will be scored according to the American
      Orthopaedic Foot and Ankle Society (AOFAS) Midfoot scale which is highly accepted for its
      validity, reliability, and reproducibility.

      Patients will also be asked about their satisfaction with the surgical results using both the
      10 cm visual analog scale (VAS) and a four-point scale (poor, mild, good, and excellent).
      Observed complications including need for further revision surgeries would be documented. All
      of this information would have been gathered during the patients' follow-up visits in the
      outpatient clinics after surgery. For those patients that receive a steel screw, they will
      receive a second outpatient surgical procedure after the 6-month postoperative follow-up to
      remove that screw using current standard orthopaedic technique.

      Postoperative foot X-rays of these patients during their follow up in the outpatient setting
      will also be examined to view proper alignment and compression of the middle portion of the
      foot together which indicates healing of the Lisfranc ligaments. Radiographs are used to
      evaluate the screw for breakage. In the case of the absorbable screw, radiographs are also
      done to assess absorption.
    

Intervention name(s): Linvatec 4.5 mm Smart Screw; Synthes 4.0 mm steel screw
Intervention type(s): Device; Device
Intervention description(s): Linvatec 4.5 mm Smart Screw to surgically fix the foot's Lisfranc ligaments; Standard steel screw use to surgically fix the foot's Lisfranc ligaments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lisfranc; fracture; dislocation; bioabsorbable