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

This study is not yet open for participant recruitment.
Verified by Rothman Institute Orthopaedics, May 2008

Sponsored by: Rothman Institute Orthopaedics
Information provided by: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT00689962
  Purpose

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.


Condition Intervention Phase
Joint Instability
Device: Linvatec 4.5 mm Smart Screw
Device: Synthes 4.0 mm steel screw
Phase IV

MedlinePlus related topics:   Foot Health    Foot Injuries and Disorders   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:   A Randomized, Prospective Comparison of Stainless Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries

Further study details as provided by Rothman Institute Orthopaedics:

Primary Outcome Measures:
  • Functional AOFAS Midfoot Score [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Analog Score for pain [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • X-rays for maintained healing [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:   60
Study Start Date:   July 2008
Estimated Study Completion Date:   July 2011
Estimated Primary Completion Date:   July 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Bioabsorbable screw fixation for Lisfranc ligaments in the foot.
Device: Linvatec 4.5 mm Smart Screw
Linvatec 4.5 mm Smart Screw to surgically fix the foot's Lisfranc ligaments
2: Active Comparator
Steel screw fixation for Lisfranc ligaments in the foot.
Device: Synthes 4.0 mm steel screw
Standard steel screw use to surgically fix the foot's Lisfranc ligaments.

Show detailed description  Show Detailed Description

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

Criteria

Inclusion Criteria:

  1. Subjects will be adults of any gender or race.
  2. Subjects will be adults between 18 and 75 years of age.
  3. The underlying diagnosis will be a Lisfranc foot injury.
  4. The indication for fixing the Lisfranc ligaments is abnormal separation of the middle part of the foot from each other.
  5. Subjects will have received either a steel or absorbable screw to fix the Lisfranc ligaments.

Exclusion Criteria:

  1. Subjects may not have any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures.
  2. Subjects may not have a history of known alcohol, analgesic, or narcotic substance abuse within 12 months prior to pretreatment.
  3. Subjects may not have a history of severe psychiatric illness such as depression or psychosis that may influence the results of administered outcome questionnaires.
  4. Subjects may not be pregnant.
  5. Subjects may be excluded from this study for any reason that may pose unnecessary risk or confounding of data, in the judgment of the investigator. This includes the 4 above points.
  6. Subjects must not have intact or normal Lisfranc ligaments in the foot.
  7. Subjects may not have a history of deep Lisfranc joint infection.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689962

Contacts
Contact: Jamal Ahmad, M.D.     215-992-4996     jamal.ahmad@rothmaninstitute.com    

Locations
United States, Pennsylvania
Nazareth Hospital     Not yet recruiting
      Philadelphia, Pennsylvania, United States, 19152
      Contact: Jamal Ahmad, M.D.     215-992-4996     jamal.ahmad@rothmaninstitute.com    
      Principal Investigator: Jamal Ahmad, M.D.            
Thomas Jefferson University Hospital     Recruiting
      Philadelphia, Pennsylvania, United States, 19107
      Contact: Steven M Raikin, M.D.     267-339-3500     steven.raikin@rothmaninstitute.com    
      Contact: Jamal Ahmad, M.D.     215-992-4996     jamal.ahmad@rothmaninstitute.com    
      Principal Investigator: Steven M Raikin, M.D.            
Riddle Memorial Hospital     Not yet recruiting
      Media, Pennsylvania, United States, 19063
      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


Publications:

Responsible Party:   Rothman Institute Orthopaedics ( Jamal Ahmad/Principal Investigator/Assistant Professor of Orthopaedic Surgery )
Study ID Numbers:   Lisfranc 1
First Received:   May 31, 2008
Last Updated:   June 3, 2008
ClinicalTrials.gov Identifier:   NCT00689962
Health Authority:   United States: Institutional Review Board

Keywords provided by Rothman Institute Orthopaedics:
Lisfranc  
fracture  
dislocation  
bioabsorbable  

Study placed in the following topic categories:
Musculoskeletal Diseases
Dislocations
Joint Diseases
Foot Injuries
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries
Joint Instability

ClinicalTrials.gov processed this record on October 10, 2008




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