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Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury

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ClinicalTrials.gov Identifier: NCT01448941
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Are Haukåen Stødle, Oslo University Hospital

October 6, 2011
October 7, 2011
May 1, 2018
October 2011
December 2017   (Final data collection date for primary outcome measure)
AOFAS Midfoot scale [ Time Frame: 2 years postoperative ]
AOFAS Midfoot scale
AOFAS Midfoot scale [ Time Frame: 2 years postoperative ]
Complete list of historical versions of study NCT01448941 on ClinicalTrials.gov Archive Site
SF-36 [ Time Frame: 2 years postoperative ]
SF-36
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 Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Lisfranc Injuries
  • Procedure: Temporary extraarticular plate fixation
    Arm 1: Primary arthrodesis TMT 1 Arm 2: Temporary extraarticular plate fixation TMT 1
  • Procedure: Primary arthrodesis
    Primary arthrodesis
  • Procedure: Primary arthrodesis TMT 2 and 3
    Primary arthrodesis TMT 2 and 3 when instability is present
  • Active Comparator: Primary arthrodesis TMT 1
    Arthrodesis TMT 1 when instability is present. Primary arthrodesis TMT 2 and 3 when instability present
    Interventions:
    • Procedure: Primary arthrodesis
    • Procedure: Primary arthrodesis TMT 2 and 3
  • Experimental: Temporary extraarticular plate fixation
    Temporary extraarticular plate fixation of TMT 1 when instability is present. Primary arthrodesis TMT 2 and 3 when instability present
    Interventions:
    • Procedure: Temporary extraarticular plate fixation
    • Procedure: Primary arthrodesis TMT 2 and 3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
50
December 2017
December 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, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01448941
206025 (REK-ID)
No
Not Provided
Plan to Share IPD: Undecided
Are Haukåen Stødle, Oslo University Hospital
Oslo University Hospital
Not Provided
Principal Investigator: Are H Stødle, cand. med. Oslo University Hospital
Oslo University Hospital
April 2018

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