Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury
Primary Purpose
Lisfranc Injuries
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Temporary extraarticular plate fixation
Primary arthrodesis
Primary arthrodesis TMT 2 and 3
Sponsored by
About this trial
This is an interventional treatment trial for Lisfranc Injuries
Eligibility 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
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Primary arthrodesis TMT 1
Temporary extraarticular plate fixation
Arm Description
Arthrodesis TMT 1 when instability is present. Primary arthrodesis TMT 2 and 3 when instability present
Temporary extraarticular plate fixation of TMT 1 when instability is present. Primary arthrodesis TMT 2 and 3 when instability present
Outcomes
Primary Outcome Measures
AOFAS Midfoot scale
AOFAS Midfoot scale
Secondary Outcome Measures
SF-36
SF-36
Full Information
NCT ID
NCT01448941
First Posted
October 6, 2011
Last Updated
March 5, 2021
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01448941
Brief Title
Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury
Official Title
Arthrodesis Versus Extra-articular Bridge Plating of the First Tarsometatarsal Joint After Acute Lisfranc Injury
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lisfranc Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Primary arthrodesis TMT 1
Arm Type
Active Comparator
Arm Description
Arthrodesis TMT 1 when instability is present. Primary arthrodesis TMT 2 and 3 when instability present
Arm Title
Temporary extraarticular plate fixation
Arm Type
Experimental
Arm Description
Temporary extraarticular plate fixation of TMT 1 when instability is present. Primary arthrodesis TMT 2 and 3 when instability present
Intervention Type
Procedure
Intervention Name(s)
Temporary extraarticular plate fixation
Intervention Description
Arm 1: Primary arthrodesis TMT 1 Arm 2: Temporary extraarticular plate fixation TMT 1
Intervention Type
Procedure
Intervention Name(s)
Primary arthrodesis
Intervention Description
Primary arthrodesis
Intervention Type
Procedure
Intervention Name(s)
Primary arthrodesis TMT 2 and 3
Intervention Description
Primary arthrodesis TMT 2 and 3 when instability is present
Primary Outcome Measure Information:
Title
AOFAS Midfoot scale
Description
AOFAS Midfoot scale
Time Frame
2 years postoperative
Secondary Outcome Measure Information:
Title
SF-36
Description
SF-36
Time Frame
2 years postoperative
Other Pre-specified Outcome Measures:
Title
ROM TMT 1 after temporary plate fixation
Description
ROM will be measured by Radiosterometric analysis (RSA)
Time Frame
1 year post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Are H Stødle, cand. med.
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury
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