Overview

This trial is active, not recruiting.

Condition lisfranc injuries
Treatment temporary extraarticular plate fixation
Sponsor Oslo University Hospital
Start date October 2011
End date August 2017
Trial size 48 participants
Trial identifier NCT01448941, 206025 (REK-ID)

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Arthrodesis TMT 1 when instability is present
temporary extraarticular plate fixation
Arm 1: arthrodesis TMT 1 Arm: 2 temporary extraarticular plate fixation TMT 1
(Experimental)
Temporary extraarticular plate fixation of TMT 1 when instability is present
temporary extraarticular plate fixation
Arm 1: arthrodesis TMT 1 Arm: 2 temporary extraarticular plate fixation TMT 1

Primary Outcomes

Measure
AOFAS Midfoot scale
time frame: 2 years postoperative

Secondary Outcomes

Measure
SF-36
time frame: 2 years postoperative

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Arthrodesis Versus Extra-articular Bridge Plating of the First Tarsometatarsal Joint After Acute Lisfranc Injury
Principal investigator Are H Stødle, cand. med.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Oslo University Hospital.