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Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01448941
Enrollment
48
Registered
2011-10-07
Start date
2011-10-31
Completion date
2017-12-31
Last updated
2021-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lisfranc Injuries

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.

Interventions

PROCEDURETemporary extraarticular plate fixation

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

Primary arthrodesis

PROCEDUREPrimary arthrodesis TMT 2 and 3

Primary arthrodesis TMT 2 and 3 when instability is present

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
AOFAS Midfoot scale2 years postoperativeAOFAS Midfoot scale

Secondary

MeasureTime frameDescription
SF-362 years postoperativeSF-36

Other

MeasureTime frameDescription
ROM TMT 1 after temporary plate fixation1 year post operativeROM will be measured by Radiosterometric analysis (RSA)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026