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Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury

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ClinicalTrials.gov Identifier: NCT01448941
Recruitment Status : Unknown
Verified October 2014 by Oslo University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 7, 2011
Last Update Posted : September 10, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Lisfranc Injuries Procedure: Temporary extraarticular plate fixation

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Arthrodesis Versus Extra-articular Bridge Plating of the First Tarsometatarsal Joint After Acute Lisfranc Injury
Study Start Date : October 2011
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. AOFAS Midfoot scale [ Time Frame: 2 years postoperative ]

Secondary Outcome Measures :
  1. SF-36 [ Time Frame: 2 years postoperative ]

Other Outcome Measures:
  1. ROM TMT 1 after temporary plate fixation [ Time Frame: 1 year post operative ]
    ROM will be measured by Radiosterometric analysis (RSA)


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448941


Locations
Norway
Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Are H Stødle, cand. med. Oslo University Hospital
More Information

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01448941     History of Changes
Other Study ID Numbers: 206025 (REK-ID)
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: September 10, 2015
Last Verified: October 2014

Additional relevant MeSH terms:
Wounds and Injuries