Back to resultsFixation of Comminuted Distal Radius Fracture
Primary Purpose
Distal Radius Fracture
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
dorsal plating
Sponsored by
About this trial
This is an interventional treatment trial for Distal Radius Fracture focused on measuring distal radius fracture
Eligibility Criteria
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
Sites / Locations
- Sohag University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
External fixator
Dorsal plate
Arm Description
patient treated by external fixator
patient treated by dorsal spanning plate
Outcomes
Primary Outcome Measures
Mayo modified wrist score
measure.grip strength
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04798846
Brief Title
Fixation of Comminuted Distal Radius Fracture
Official Title
Spanning Plate Versus Spanning External Fixator in Fixation of Comminuted Distal Radius Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
comparison between different methods in fixation of comminuted distal radius fractures
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
Keywords
distal radius fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
External fixator
Arm Type
Active Comparator
Arm Description
patient treated by external fixator
Arm Title
Dorsal plate
Arm Type
Active Comparator
Arm Description
patient treated by dorsal spanning plate
Intervention Type
Procedure
Intervention Name(s)
dorsal plating
Other Intervention Name(s)
External fixator
Intervention Description
Spanning Plate inserted dorsally below tendons Spanning External Fixator by rods inserted in distal radius and metacarpals
Primary Outcome Measure Information:
Title
Mayo modified wrist score
Description
measure.grip strength
Time Frame
up to 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Fixation of Comminuted Distal Radius Fracture
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