NCT05573516

Brief Summary

A clinical trial comparing the outcomes of fixation of medial malleolar fractures either by fully threaded uni-cortical 4mm positional screws vs 4mm lag screws.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 18, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

October 5, 2022

Last Update Submit

October 6, 2022

Conditions

Medial Malleolus FractureAnkle Fractures

Outcome Measures

Primary Outcomes (1)

  • AOFAS score

    6 wks (this time when the fracture has usually healed and the patients cat bear weight on the limb)

Study Arms (2)

Fixation with 4mm lag screws

EXPERIMENTAL
Procedure: Open reduction and internal fixation

Fixation with 4mm fully-threaded positional screws

ACTIVE COMPARATOR
Procedure: Open reduction and internal fixation

Interventions

Open reduction and internal fixationPROCEDURE

unicortical fully threaded 4mm screws will be used as positional screws after completely reducing the fracture

Fixation with 4mm fully-threaded positional screwsFixation with 4mm lag screws

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Displaced medial malleolar fractures (Herscovici type B and C) that can be fixed with screws.

You may not qualify if:

  • Open fractures,
  • Age \<18 or \> 70,
  • Pathological fractures,
  • Patients with DM,
  • Type A and D fractures according to the Herscovici system(As these fractures would require screws to be positioned horizontally),
  • associated tibial plafond fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Al Ainy-Cairo University- Faculty of Medicine

Cairo, Manial, 11956, Egypt

RECRUITING

MeSH Terms

Conditions

Ankle Fractures

Interventions

Open Fracture ReductionFracture Fixation, Internal

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Central Study Contacts

Ahmed O Sabry, MBBS

CONTACT

+201117632926sniperrifle22@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 5, 2022

First Posted

October 10, 2022

Study Start

August 18, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

October 10, 2022

Record last verified: 2022-10

Locations

EG(1)