Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Oslo University Hospital
Information provided by (Responsible Party):
Oslo University Hospital Identifier:
First received: October 6, 2011
Last updated: October 30, 2014
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)

Estimated Enrollment: 50
Study Start Date: October 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2015 (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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01448941

Contact: Are H Stødle, cand. med.
Contact: Kjetil H Hvaal, Ph.D

Oslo University Hospital Recruiting
Oslo, Norway
Contact: Are H Stødle, cand. med.   
Contact: Kjetil Hvaal, Ph.D   
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: October 30, 2014
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 March 03, 2015