NCT04605341

Brief Summary

To compare between buried k wires and miniplate in management of metacarpal fracture.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

September 12, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

October 28, 2020

Status Verified

September 1, 2020

Enrollment Period

1.9 years

First QC Date

September 12, 2020

Last Update Submit

October 21, 2020

Conditions

Metacarpal Fracture

Outcome Measures

Primary Outcomes (1)

  • miniplate,buried k wires and union

    • To compare between union and healing in metacarpal fracture fixation by miniplate versus buried intramedullary k. wires by imaging using anteroposterior and lateral and oblique views x ray to determine union and healing by seeing bridging callus in two or more cortices

    6 month

Secondary Outcomes (1)

  • Range of motion

    6 month

Study Arms (2)

group one

ACTIVE COMPARATOR

patient with metacarpal fracture that will use minipate for fixation

Device: miniplate

gruop two

ACTIVE COMPARATOR

patient with metacarpal fracture that will use buried k wires for fixation

Device: miniplate

Interventions

miniplateDEVICE

comparison between k wires and miniplate in metacarpal fractures

Also known as: k wires
group onegruop two

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: ( 20-60) years,
  • Fresh (fixed within 3 days),
  • Single or multiple fractures of metacarpals.

You may not qualify if:

  • Pathological fracture,
  • Major systemic illness, malignancy,
  • Patient on drugs affecting fracture healing like steroid, anticancer drugs,
  • Polytrauma patients,
  • Extensive comminution of the metacarpal or phalanx detected pre- or intra-operatively,
  • Dislocations at either end of the fractured bone
  • Parents/guardians/patients not willing to participate in study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Bone Wires

Intervention Hierarchy (Ancestors)

Internal FixatorsProstheses and ImplantsEquipment and SuppliesOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentSurgical Fixation Devices

Central Study Contacts

mina kamal, resident

CONTACT

01203380329minakamalcr7@gmail.com

kamal elgafary, professor

CONTACT

01223144899Kamalelgafary@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

September 12, 2020

First Posted

October 28, 2020

Study Start

January 1, 2021

Primary Completion

November 30, 2022

Study Completion

December 31, 2022

Last Updated

October 28, 2020

Record last verified: 2020-09