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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Rothman Institute Orthopaedics
Sponsor:
Information provided by (Responsible Party):
Jamal Ahmad, Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:
NCT00985023
First received: September 23, 2009
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Unstable Lisfranc Fracture-dislocations of the Midfoot
Procedure: Steel screw fixation of Lisfranc fracture-dislocation.
Procedure: Absorbable screw fixation of Lisfranc fracture-dislocations.
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective Comparison of Stainless Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries

Resource links provided by NLM:


Further study details as provided by Rothman Institute Orthopaedics:

Primary Outcome Measures:
  • Return to pre-injury level of function. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Restoration of normal midfoot alignment and stability. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2008
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Steel screw fixation Procedure: Steel screw fixation of Lisfranc fracture-dislocation.
Stainless steel screw fixation of unstable Lisfranc fracture-dislocations of the midfoot.
Other Name: Steel screw
Experimental: Bioabsorbable screw fixation Procedure: Absorbable screw fixation of Lisfranc fracture-dislocations.
Bioabsorbable (poly-levo-lactic acid) screw fixation of unstable Lisfranc fracture-dislocations of the midfoot.
Other Name: Smart Screw

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Subjects must not have intact or normal Lisfranc ligaments in the foot.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985023

Locations
United States, Pennsylvania
Riddle Memorial Hospital Recruiting
Media, Pennsylvania, United States, 19063
Contact: Jamal Ahmad, M.D.    215-992-4996    jamal.ahmad@rothmaninstitute.com   
Principal Investigator: Jamal Ahmad, M.D.         
Nazareth Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19152
Contact: Jamal Ahmad, M.D.    215-992-4996    jamal.ahmad@rothmaninstitute.com   
Principal Investigator: Jamal Ahmad, M.D.         
Sponsors and Collaborators
Rothman Institute Orthopaedics
Investigators
Principal Investigator: Jamal Ahmad, M.D. Rothman Institute Orthopaedics
  More Information

No publications provided

Responsible Party: Jamal Ahmad, Assistant Professor of Orthopaedic Surgery, Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT00985023     History of Changes
Other Study ID Numbers: Lisfranc
Study First Received: September 23, 2009
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rothman Institute Orthopaedics:
Unstable
Lisfranc
fracture
dislocation
midfoot

Additional relevant MeSH terms:
Dislocations
Foot Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 22, 2014