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Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2014 by Oslo University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01448941
First Posted: October 7, 2011
Last Update Posted: September 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Oslo University Hospital
October 6, 2011
October 7, 2011
September 10, 2015
October 2011
August 2017   (Final data collection date for primary outcome measure)
AOFAS Midfoot scale [ Time Frame: 2 years postoperative ]
Same as current
Complete list of historical versions of study NCT01448941 on ClinicalTrials.gov Archive Site
SF-36 [ Time Frame: 2 years postoperative ]
EQ-5d [ Time Frame: 2 years postoperative ]
ROM TMT 1 after temporary plate fixation [ Time Frame: 1 year post operative ]
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
Intervention Model: Parallel Assignment
Masking: None (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.
 
Unknown status
48
August 2017
August 2017   (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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01448941
206025 (REK-ID)
No
Not Provided
Not Provided
Oslo University Hospital
Oslo University Hospital
Not Provided
Principal Investigator: Are H Stødle, cand. med. Oslo University Hospital
Oslo University Hospital
October 2014

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