Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury

This study is currently recruiting participants.
Verified December 2013 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01448941
First received: October 6, 2011
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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: December 2016
Estimated Primary Completion Date: December 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448941

Contacts
Contact: Are H Stødle, cand. med. arestodle@gmail.com
Contact: Kjetil H Hvaal, Ph.D khvaal@gmail.com

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Are H Stødle, cand. med.       arestodle@gmail.com   
Contact: Kjetil Hvaal, Ph.D       khvaal@gmail.com   
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Are H Stødle, cand. med. Oslo University Hospital
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01448941     History of Changes
Other Study ID Numbers: 206025 (REK-ID)
Study First Received: October 6, 2011
Last Updated: December 11, 2013
Health Authority: Norway: The National committees for Research and Ethics in Norway
Norway: Norwegian Social Science Data Service
Norway: Directorate of Health

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on April 22, 2014