NCT01448941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2011

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 9, 2021

Status Verified

April 1, 2018

Enrollment Period

6.2 years

First QC Date

October 6, 2011

Last Update Submit

March 5, 2021

Conditions

Lisfranc Injuries

Outcome Measures

Primary Outcomes (1)

  • AOFAS Midfoot scale

    AOFAS Midfoot scale

    2 years postoperative

Secondary Outcomes (1)

  • SF-36

    2 years postoperative

Other Outcomes (1)

  • ROM TMT 1 after temporary plate fixation

    1 year post operative

Study Arms (2)

Primary arthrodesis TMT 1

ACTIVE COMPARATOR

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

Procedure: Primary arthrodesisProcedure: Primary arthrodesis TMT 2 and 3

Temporary extraarticular plate fixation

EXPERIMENTAL

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

Procedure: Temporary extraarticular plate fixationProcedure: Primary arthrodesis TMT 2 and 3

Interventions

Temporary extraarticular plate fixationPROCEDURE

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

Temporary extraarticular plate fixation
Primary arthrodesisPROCEDURE

Primary arthrodesis

Primary arthrodesis TMT 1
Primary arthrodesis TMT 2 and 3PROCEDURE

Primary arthrodesis TMT 2 and 3 when instability is present

Primary arthrodesis TMT 1Temporary extraarticular plate fixation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lisfranc injuries with instability off TMT1, and fracture/instability of TMT 2 and 3. No major fracture in relation to TMT1.
  • Age 18-65

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Study Officials

  • Are H Stødle, cand. med.

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 6, 2011

First Posted

October 7, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 9, 2021

Record last verified: 2018-04

Locations

NO(1)