Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury

NCT ID: NCT01448941

Last Updated: 2021-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Lisfranc Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Primary arthrodesis TMT 1

Arthrodesis TMT 1 when instability is present. Primary arthrodesis TMT 2 and 3 when instability present

Group Type ACTIVE_COMPARATOR

Primary arthrodesis

Intervention Type PROCEDURE

Primary arthrodesis

Primary arthrodesis TMT 2 and 3

Intervention Type PROCEDURE

Primary arthrodesis TMT 2 and 3 when instability is present

Temporary extraarticular plate fixation

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

Group Type EXPERIMENTAL

Temporary extraarticular plate fixation

Intervention Type PROCEDURE

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

Primary arthrodesis TMT 2 and 3

Intervention Type PROCEDURE

Primary arthrodesis TMT 2 and 3 when instability is present

Interventions

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Temporary extraarticular plate fixation

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

Intervention Type PROCEDURE

Primary arthrodesis

Primary arthrodesis

Intervention Type PROCEDURE

Primary arthrodesis TMT 2 and 3

Primary arthrodesis TMT 2 and 3 when instability is present

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Are Haukåen Stødle

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Are H Stødle, cand. med.

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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206025 (REK-ID)

Identifier Type: -

Identifier Source: org_study_id

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