NCT06210191

Brief Summary

Intramedullary headless screw fixation for metacarpal and phalangeal fractures

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
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

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

December 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

December 18, 2023

Last Update Submit

February 8, 2024

Conditions

Metacarpal FracturePhalanx Fracture

Keywords

intramedullary headless screw fixation

Outcome Measures

Primary Outcomes (1)

  • Achieve full range of motion of hand joints

    Change DASH Score of hand functions to 0 by this intervention. As 0 is excellent and 100 is the worst outcome

    6 weeks for active range of motion

Study Arms (1)

union of fracture

EXPERIMENTAL

Intramedullary headless screw fixation for metacarpal and phalangeal fractures

Procedure: Intramedullary headless screw fixation

Interventions

Intramedullary headless screw fixationPROCEDURE

fixation of fractures of metacarpals and phalanges by intramedullary headless screws

union of fracture

Eligibility Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Skeletally mature patients with closed fractures of phalanges and metacarpals.
  • Patients with open type I fractures of phalanges and metacarpals.

You may not qualify if:

  • Skeletally immature patients with open physis.
  • Patients with open type II or III fractures of phalanges or metacarpals.
  • Patients with fractures of phalanges or metacarpals with neurovascular injury. 4 Patients with associated tendon injuries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Asyut, 71515, Egypt

Location

Study Officials

  • Amr Elsayed, professor

    Assiut University

    STUDY CHAIR

  • Waleed Riad, professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Ahmed Megahed, resident

CONTACT

+201007712309megahed117@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 18, 2023

First Posted

January 18, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

February 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

There is a plan to make IPD and related data dictionaries available. all collected IPD, all IPD that underlie results in a publication)

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
starting in January 2025 or as a date relative to the time when summary data are published
Access Criteria
access criteria of my IPD will be available with my investigators

Locations

EG(1)