NCT03367169

Brief Summary

The assessment consists in comparing the osteosynthesis plate with minimally invasive technique versus open reduction and internal fixation. The aim of study is to compare (period of bandage, efficacy, safety), these two types of surgical technique by using a prospective, randomized analysis.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

November 23, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

November 23, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2024

Completed
Last Updated

May 3, 2024

Status Verified

April 1, 2024

Enrollment Period

6.4 years

First QC Date

November 23, 2017

Last Update Submit

May 2, 2024

Conditions

Pilon FracturesFracturesBoneLeg Injuries

Keywords

Pilon fracturesOsteosynthesisMini invasive plate osteosynthesisLocked plateOpen reduction

Outcome Measures

Primary Outcomes (1)

  • Healing

    Measure of the duration of the bandage with index form of follow-up the state cutaneous of the wound. This measure was a number.

    at 45 days

Secondary Outcomes (6)

  • AOFAS clinical score

    pre op, 45 days, 3, 6 and 12 months

  • Nach mazur and al score

    pre op 45 days, 3, 6 and 12 months

  • The Foot & Ankle Disability Index

    pre op 45 days, 3, 6 and 12 months

  • Pain

    pre op 45 days, 3, 6 and 12 months

  • Complications

    pre op 45 days, 3, 6 and 12 months

  • +1 more secondary outcomes

Study Arms (2)

minimally invasive method

ACTIVE COMPARATOR

The patients are treated with minimally invasive method

Procedure: minimally invasive method

open reduction method

ACTIVE COMPARATOR

The patients are treated with open reduction method

Procedure: open reduction method

Interventions

minimally invasive methodPROCEDURE

type of surgical technique

minimally invasive method
open reduction methodPROCEDURE

type of surgical technique

open reduction method

Eligibility Criteria

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

You may qualify if:

  • More than 18-year-old with opened or closed pilon fracture Cauchoix type 1,
  • signed patient consent

You may not qualify if:

  • Open pilon fracture cauchoix type 2 or 3,
  • infection of the operating site,
  • previous osseous disease
  • patient who are unwilling or unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Fractures, BoneLeg Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Roger ERIVAN

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2017

First Posted

December 8, 2017

Study Start

November 23, 2017

Primary Completion

April 26, 2024

Study Completion

April 26, 2024

Last Updated

May 3, 2024

Record last verified: 2024-04

Locations

FR(1)