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Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury

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ClinicalTrials.gov Identifier: NCT01448941
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Are Haukåen Stødle, Oslo University Hospital

Brief Summary:
The purpose of this study is to compare arthrodesis of the first TMT-joint to extraarticular bridge plate fixation of the same joint in acute Lisfranc injuries.

Condition or disease Intervention/treatment Phase
Lisfranc Injuries Procedure: Temporary extraarticular plate fixation Procedure: Primary arthrodesis Procedure: Primary arthrodesis TMT 2 and 3 Not Applicable

Detailed Description:

We want to compare arthrodesis of TMT 1 to temporary bridge plating of TMT 1 in acute Lisfranc injuries where at least tarsometatarsal joints 1-3 are involved.

We preform arthrodesis of TMT 2 and 3 in both groups.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Arthrodesis Versus Extra-articular Bridge Plating of the First Tarsometatarsal Joint After Acute Lisfranc Injury
Study Start Date : October 2011
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Active Comparator: Primary arthrodesis TMT 1
Arthrodesis TMT 1 when instability is present. Primary arthrodesis TMT 2 and 3 when instability present
Procedure: Primary arthrodesis
Primary arthrodesis
Procedure: Primary arthrodesis TMT 2 and 3
Primary arthrodesis TMT 2 and 3 when instability is present
Experimental: Temporary extraarticular plate fixation
Temporary extraarticular plate fixation of TMT 1 when instability is present. Primary arthrodesis TMT 2 and 3 when instability present
Procedure: Temporary extraarticular plate fixation
Arm 1: Primary arthrodesis TMT 1 Arm 2: Temporary extraarticular plate fixation TMT 1
Procedure: Primary arthrodesis TMT 2 and 3
Primary arthrodesis TMT 2 and 3 when instability is present



Primary Outcome Measures :
  1. AOFAS Midfoot scale [ Time Frame: 2 years postoperative ]
    AOFAS Midfoot scale


Secondary Outcome Measures :
  1. SF-36 [ Time Frame: 2 years postoperative ]
    SF-36


Other Outcome Measures:
  1. ROM TMT 1 after temporary plate fixation [ Time Frame: 1 year post operative ]
    ROM will be measured by Radiosterometric analysis (RSA)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Lisfranc injuries with instability off TMT1, and fracture/instability of TMT 2 and 3. No major fracture in relation to TMT1.
  • Age 18-65

Exclusion Criteria:

  • Feet with other major foot/ankle injuries
  • Previous foot infection or foot pathology on affected side
  • Previous surgery to the TMT joints
  • Sequelae after previous foot injuries
  • Diabetes mellitus, neuropathy and peripheral vascular disease

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): NCT01448941


Locations
Norway
Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Are H Stødle, cand. med. Oslo University Hospital

Responsible Party: Are Haukåen Stødle, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01448941     History of Changes
Other Study ID Numbers: 206025 (REK-ID)
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Wounds and Injuries