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Fixation of Comminuted Distal Radius Fracture

Sponsor
Sohag University (Other)
Overall Status
Completed
CT.gov ID
NCT04798846
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
12
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

comparison between different methods in fixation of comminuted distal radius fractures

Condition or Disease Intervention/Treatment Phase
  • Procedure: dorsal plating
 N/A

Detailed Description

This clinical study aims at comparison of treatment outcomes of Spanning plate versus spanning External fixator in fixation of comminuted distal radius fracture.

The primary outcomes that we like to measure are pain, healing. Stiffness and range of motion .

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Spanning Plate Versus Spanning External Fixator in Fixation of Comminuted Distal Radius Fracture
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Apr 1, 2022
Actual Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: External fixator

patient treated by external fixator

Procedure: dorsal plating
Spanning Plate inserted dorsally below tendons Spanning External Fixator by rods inserted in distal radius and metacarpals
Other Names:
  • External fixator

    		•
    Active Comparator: Dorsal plate

    patient treated by dorsal spanning plate

    Procedure: dorsal plating
    Spanning Plate inserted dorsally below tendons Spanning External Fixator by rods inserted in distal radius and metacarpals
    Other Names:
  • External fixator

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mayo modified wrist score [up to 6 month]

      measure.grip strength

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    • Inclusion criteria

    • Skeletally mature patients aging 18 or more

    • Comminuted distal radius fractures Fernandez type V

    • Exclusion criteria

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sohag University Hospital Sohag Egypt

    Sponsors and Collaborators

    • Sohag University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eslam Abdelnaby Abdelsabor, principal investigator, Sohag University
    ClinicalTrials.gov Identifier:
    NCT04798846
    Other Study ID Numbers:
    • Soh_Med_21_02_11
    First Posted:
    Mar 15, 2021
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eslam Abdelnaby Abdelsabor, principal investigator, Sohag University
    distal radius fracture
    Additional relevant MeSH terms:
    Fractures, Bone
    Radius Fractures

    Study Results

    No Results Posted as of Jun 21, 2022