Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury

This study is currently recruiting participants. (see Contacts and Locations)
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

October 6, 2011
December 11, 2013
October 2011
December 2014   (final data collection date for primary outcome measure)
AOFAS Midfoot scale [ Time Frame: 2 years postoperative ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01448941 on ClinicalTrials.gov Archive Site
SF-36 [ Time Frame: 2 years postoperative ] [ Designated as safety issue: No ]
EQ-5d [ Time Frame: 2 years postoperative ] [ Designated as safety issue: No ]
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)
Not Provided
 
Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury
Arthrodesis Versus Extra-articular Bridge Plating of the First Tarsometatarsal Joint After Acute Lisfranc Injury

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lisfranc Injuries
Procedure: Temporary extraarticular plate fixation
Arm 1: arthrodesis TMT 1 Arm: 2 temporary extraarticular plate fixation TMT 1
  • Active Comparator: Arthrodesis TMT 1
    Arthrodesis TMT 1 when instability is present
    Intervention: Procedure: Temporary extraarticular plate fixation
  • Experimental: Temporary extraarticular plate fixation
    Temporary extraarticular plate fixation of TMT 1 when instability is present
    Intervention: Procedure: Temporary extraarticular plate fixation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2016
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Are H Stødle, cand. med. arestodle@gmail.com
Contact: Kjetil H Hvaal, Ph.D khvaal@gmail.com
Norway
 
NCT01448941
206025 (REK-ID)
No
Oslo University Hospital
Oslo University Hospital
Not Provided
Principal Investigator: Are H Stødle, cand. med. Oslo University Hospital
Oslo University Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP