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Completed

NCT Number: NCT01448941

Arthrodesis Versus Extra-articular Plate Fixation in 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.

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Key information

Conditions

Lisfranc Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Temporary extraarticular plate fixation

Procedure

Arm 1: Primary arthrodesis TMT 1 Arm 2: Temporary extraarticular plate fixation TMT 1

Primary arthrodesis

Procedure

Primary arthrodesis

Primary arthrodesis TMT 2 and 3

Procedure

Primary arthrodesis TMT 2 and 3 when instability is present

Primary outcomes

  1. AOFAS Midfoot scale

    Time frame: 2 years postoperative

    AOFAS Midfoot scale

Secondary outcomes

  1. SF-36

    Time frame: 2 years postoperative

    SF-36

Other outcomes

  1. ROM TMT 1 after temporary plate fixation

    Time frame: 1 year post operative

    ROM will be measured by Radiosterometric analysis (RSA)

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Arthrodesis Versus Extra-articular Bridge Plating of the First Tarsometatarsal Joint After Acute Lisfranc Injury

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Oct 7, 2011
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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