Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury

Lisfranc Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448941
• Other study ID #: 206025 (REK-ID)
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lisfranc Injuries
• Wounds and Injuries

Intervention

Procedure:
• Temporary extraarticular plate fixation
Arm 1: Primary arthrodesis TMT 1 Arm 2: Temporary extraarticular plate fixation TMT 1
• Primary arthrodesis
Primary arthrodesis
• Primary arthrodesis TMT 2 and 3
Primary arthrodesis TMT 2 and 3 when instability is present

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ROM TMT 1 after temporary plate fixation	ROM will be measured by Radiosterometric analysis (RSA)	1 year post operative
Primary	AOFAS Midfoot scale	AOFAS Midfoot scale	2 years postoperative
Secondary	SF-36	SF-36	2 years postoperative