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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014