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

This study is currently recruiting participants.
Verified May 2013 by Rothman Institute Orthopaedics
Sponsor:
Information provided by (Responsible Party):
Jamal Ahmad, Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:
NCT00689962
First received: May 31, 2008
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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:

U.S. FDA Resources

Further study details as provided by Rothman Institute Orthopaedics:

Primary Outcome Measures:
  • Foot and Ankle Ability Measures [ 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 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients with unstable Lisfranc foot fracture-dislocations that receive bioabsorbable screw fixation through surgery.
 Device: Linvatec 4.5 mm Smart Screw
Linvatec 4.5 mm Smart Screw to surgically fix the foot's Lisfranc ligaments
Other Name: Linvatec 4.5 mm Smart Screw
Active Comparator: 2
Patients with unstable Lisfranc fracture-dislocations of the foot that receive steel screw fixation through surgery.
 Device: Synthes 4.0 mm steel screw
Standard steel screw use to surgically fix the foot's Lisfranc ligaments.
Other Name: Synthes 4.0 mm steel screw

  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
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

Publications:

Responsible Party: Jamal Ahmad, Assistant Professor of Orthopaedic Surgery, Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT00689962     History of Changes
Other Study ID Numbers: Lisfranc 1
Study First Received: May 31, 2008
Last Updated: May 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rothman Institute Orthopaedics:
Lisfranc
fracture
dislocation
bioabsorbable

Additional relevant MeSH terms:
Joint Instability
Foot Injuries
Joint Diseases
 Musculoskeletal Diseases
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013