Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Oslo University Hospital Identifier:
First received: October 6, 2011
Last updated: September 9, 2015
Last verified: October 2014

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 Intervention
Lisfranc Injuries
Procedure: Temporary extraarticular plate fixation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Arthrodesis Versus Extra-articular Bridge Plating of the First Tarsometatarsal Joint After Acute Lisfranc Injury

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • AOFAS Midfoot scale [ Time Frame: 2 years postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF-36 [ Time Frame: 2 years postoperative ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • ROM TMT 1 after temporary plate fixation [ Time Frame: 1 year post operative ] [ Designated as safety issue: No ]
    ROM will be measured by Radiosterometric analysis (RSA)

Enrollment: 48
Study Start Date: October 2011
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arthrodesis TMT 1
Arthrodesis TMT 1 when instability is present
Procedure: Temporary extraarticular plate fixation
Arm 1: arthrodesis TMT 1 Arm: 2 temporary extraarticular plate fixation TMT 1
Experimental: Temporary extraarticular plate fixation
Temporary extraarticular plate fixation of TMT 1 when instability is present
Procedure: Temporary extraarticular plate fixation
Arm 1: arthrodesis TMT 1 Arm: 2 temporary extraarticular plate fixation TMT 1

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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01448941

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

No publications provided

Responsible Party: Oslo University Hospital Identifier: NCT01448941     History of Changes
Other Study ID Numbers: 206025 (REK-ID)
Study First Received: October 6, 2011
Last Updated: September 9, 2015
Health Authority: Norway: The National committees for Research and Ethics in Norway
Norway: Norwegian Social Science Data Service
Norway: Directorate of Health processed this record on October 06, 2015