Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury

Not Applicable

Completed

• Conditions: Lisfranc Injuries
• Interventions: Procedure: Primary arthrodesis; Procedure: Temporary extraarticular plate fixation; Procedure: Primary arthrodesis TMT 2 and 3

• Registration Number: NCT01448941
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-04
• Last Update Submitted: 2021-03-05
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary arthrodesis TMT 1	Primary arthrodesis	Arthrodesis TMT 1 when instability is present. Primary arthrodesis TMT 2 and 3 when instability present
Primary arthrodesis TMT 1	Primary arthrodesis TMT 2 and 3	Arthrodesis TMT 1 when instability is present. Primary arthrodesis TMT 2 and 3 when instability present
Temporary extraarticular plate fixation	Temporary extraarticular plate fixation	Temporary extraarticular plate fixation of TMT 1 when instability is present. Primary arthrodesis TMT 2 and 3 when instability present
Temporary extraarticular plate fixation	Primary arthrodesis TMT 2 and 3	Temporary extraarticular plate fixation of TMT 1 when instability is present. Primary arthrodesis TMT 2 and 3 when instability present

Primary Outcome Measures

Name	Time	Method
AOFAS Midfoot scale	2 years postoperative	AOFAS Midfoot scale

Secondary Outcome Measures

Name	Time	Method
SF-36	2 years postoperative	SF-36

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway