NCT06182904

Brief Summary

Management of pilon fractures with versus without fibula fixation

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Status
not yet recruiting

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

June 30, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 27, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

March 21, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2026

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2026

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

1.9 years

First QC Date

June 30, 2023

Last Update Submit

December 24, 2023

Conditions

Pilon Fracture

Outcome Measures

Primary Outcomes (1)

  • Fracture healing and bone union

    by RUST score

    Baseline

Secondary Outcomes (1)

  • Incidece and rate of complications

    Baseline

Study Arms (2)

1

Management of pilon fractures with fibula fixation

Device: Dynamic compression plate

2

Management of pilon fracture without fibula fixation

Interventions

Dynamic compression plateDEVICE

Fixation of fibula in some cases with dynamic compression plate

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Management of pilon fractures with versus withot fibula fixation: prospective controlled study

You may qualify if:

  • patients with metaphyseal non rotational pilon or distal tibia : age ( 18 \_ 65 )
  • No skin troubles
  • No infections
  • Non-dibetic patients.

You may not qualify if:

  • Patients who will not complete their follow up.
  • Skin troubles
  • Infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Mina Mofdy

CONTACT

01286998347minamofdy55@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

June 30, 2023

First Posted

December 27, 2023

Study Start

March 21, 2024

Primary Completion

February 27, 2026

Study Completion

March 21, 2026

Last Updated

December 27, 2023

Record last verified: 2023-12