The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 14 for:    lisfranc
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00985023
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Jamal Ahmad, Rothman Institute Orthopaedics

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment 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

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective Comparison of Stainless Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries
Study Start Date : August 2008
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Return to pre-injury level of function. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Restoration of normal midfoot alignment and stability. [ Time Frame: 2 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985023


Locations
Layout table for location information
United States, Pennsylvania
Riddle Memorial Hospital
Media, Pennsylvania, United States, 19063
Nazareth Hospital
Philadelphia, Pennsylvania, United States, 19152
Sponsors and Collaborators
Rothman Institute Orthopaedics
Investigators
Layout table for investigator information
Principal Investigator: Jamal Ahmad, M.D. Rothman Institute Orthopaedics
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jamal Ahmad, Assistant Professor of Orthopaedic Surgery, Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT00985023    
Other Study ID Numbers: Lisfranc
First Posted: September 25, 2009    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Keywords provided by Jamal Ahmad, Rothman Institute Orthopaedics:
Unstable
Lisfranc
fracture
dislocation
midfoot
Additional relevant MeSH terms:
Layout table for MeSH terms
Joint Dislocations
Fracture Dislocation
Foot Injuries
Fractures, Bone
 Wounds and Injuries
Joint Diseases
Musculoskeletal Diseases
Leg Injuries