Back to resultsPercutaneous Fixation of Acute Scaphoid Fractures
Primary Purpose
Scaphoid Fracture
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Percutaneous fixation of acute Scaphoid fractures
Sponsored by
About this trial
This is an interventional treatment trial for Scaphoid Fracture
Eligibility Criteria
Inclusion Criteria:
- - Acute stable non displaced waist fracture (A2).
- Acute unstable oblique distal third (B1).
- Acute unstable displaced waist (B2).
- Acute un stable fracture dislocation (B4).
- Acute un stable comminuted fracture (B5).
Exclusion Criteria:
- - Acute stable fracture tubercle (A1).
- Acute unstable fracture proximal pole (B3).
- Delayed union fracture (C).
- Established non-union fracture includes fibrous (D1) and sclerotic (D2).
- Bilateral fractures because of possible interference with postoperative grip strength measurement.
Sites / Locations
- Sohag university hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
group (1)
Arm Description
group (1) who are complaining of acute scaphoid fractures,we will do percutaneous trans trapezial fixation of scaphoid by Herbert screw.Short arm circular cast including the thumb will be applied. After 3 weeks, cast will be removed and exercises will start.
Outcomes
Primary Outcome Measures
Change of wrist power
Modified Mayo wrist score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04776551
Brief Title
Percutaneous Fixation of Acute Scaphoid Fractures
Official Title
Percutaneous Trans-trapezial Fixation of Acute Scaphoid Fractures by Herbert Screw
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
May 1, 2022 (Actual)
Study Completion Date
May 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
Percutaneous Trans-trapezial fixation of acute Scaphoid fractures by Herbert screw
Detailed Description
Aim of the work:
To assessment outcomes of percutaneous Trans-trapezial fixation of acute scaphoid fracture.
Operative Technique:
Anesthesia: carried out under general anesthesia or brachial plexus block and under tourniquet control.
Position: supine. Approach: Percutaneous Trans-trapezial fixation of acute Scaphoid fracture. Recording any intraoperative complication that may affect the result.
Postoperative Follow Up:
Short arm circular cast including the thumb will be applied. After 3 weeks, cast will be removed and exercises will start.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scaphoid Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group (1)
Arm Type
Other
Arm Description
group (1) who are complaining of acute scaphoid fractures,we will do percutaneous trans trapezial fixation of scaphoid by Herbert screw.Short arm circular cast including the thumb will be applied. After 3 weeks, cast will be removed and exercises will start.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous fixation of acute Scaphoid fractures
Intervention Description
Percutaneous Trans-trapezial fixation of acute Scaphoid fractures by Herbert screw
Primary Outcome Measure Information:
Title
Change of wrist power
Description
Modified Mayo wrist score
Time Frame
Up to 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Acute stable non displaced waist fracture (A2).
Acute unstable oblique distal third (B1).
Acute unstable displaced waist (B2).
Acute un stable fracture dislocation (B4).
Acute un stable comminuted fracture (B5).
Exclusion Criteria:
- Acute stable fracture tubercle (A1).
Acute unstable fracture proximal pole (B3).
Delayed union fracture (C).
Established non-union fracture includes fibrous (D1) and sclerotic (D2).
Bilateral fractures because of possible interference with postoperative grip strength measurement.
Facility Information:
Facility Name
Sohag university hospital
City
Sohag
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Percutaneous Fixation of Acute Scaphoid Fractures
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