NCT04798846

Brief Summary

comparison between different methods in fixation of comminuted distal radius fractures

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

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

February 23, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

1 year

First QC Date

February 23, 2021

Last Update Submit

June 14, 2022

Conditions

Distal Radius Fracture

Keywords

distal radius fracture

Outcome Measures

Primary Outcomes (1)

  • Mayo modified wrist score

    measure.grip strength

    up to 6 month

Study Arms (2)

External fixator

ACTIVE COMPARATOR

patient treated by external fixator

Procedure: dorsal plating

Dorsal plate

ACTIVE COMPARATOR

patient treated by dorsal spanning plate

Procedure: dorsal plating

Interventions

dorsal platingPROCEDURE

Spanning Plate inserted dorsally below tendons Spanning External Fixator by rods inserted in distal radius and metacarpals

Also known as: External fixator
Dorsal plateExternal fixator

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Skeletally mature patients aging 18 or more
  • Comminuted distal radius fractures Fernandez type V

You may not qualify if:

  • Age less than 18 year or more
  • Patients with previous fracture affecting wrist joint in the same side.
  • Parients with active infection in the affected joint
  • Pathological fracture
  • Neurological disorder (epilepsy…etc) Reheumatoid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

MeSH Terms

Conditions

Wrist Fractures

Interventions

External Fixators

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Orthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

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

February 23, 2021

First Posted

March 15, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

June 21, 2022

Record last verified: 2022-06

Locations

EG(1)