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.

Study Overview

• Status: Completed
• Conditions: Lisfranc Injuries
• Intervention / Treatment: Procedure: Primary arthrodesis; Procedure: Primary arthrodesis TMT 2 and 3; 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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Primary arthrodesis TMT 1; Arthrodesis TMT 1 when instability is present. Primary arthrodesis TMT 2 and 3 when instability present	Procedure: Primary arthrodesis; Primary arthrodesis; Procedure: Primary arthrodesis TMT 2 and 3; Primary arthrodesis TMT 2 and 3 when instability is present
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	Procedure: Primary arthrodesis TMT 2 and 3; Primary arthrodesis TMT 2 and 3 when instability is present; Procedure: Temporary extraarticular plate fixation; Arm 1: Primary arthrodesis TMT 1 Arm 2: Temporary extraarticular plate fixation TMT 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AOFAS Midfoot scale	AOFAS Midfoot scale	2 years postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36	SF-36	2 years postoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ROM TMT 1 after temporary plate fixation	ROM will be measured by Radiosterometric analysis (RSA)	1 year post operative

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Are H Stødle, cand. med., Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: October 6, 2011
• First Submitted That Met QC Criteria: October 6, 2011
• First Posted (Estimate): October 7, 2011

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 206025 (REK-ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided