Back to resultsManagement of Distal Ulna Fractures Using Hook Plate
Primary Purpose
Distal Ulna Fractures
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hook plate
Sponsored by
About this trial
This is an interventional treatment trial for Distal Ulna Fractures
Eligibility Criteria
Inclusion Criteria:
- Skeletally mature distal ulna fracture with or without radius fracture.
Exclusion Criteria:
- Pathological fracture Skeletally immaturity Neurovascular problems
Sites / Locations
- Sohag University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
adult patients with distal ulna fractures
Arm Description
adult patients with distal ulna fractures
Outcomes
Primary Outcome Measures
Management of Distal Ulna Fractures Using Hook Plate
surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04792060
Brief Title
Management of Distal Ulna Fractures Using Hook Plate
Official Title
Prospective Study of the Management of Distal Ulna Fractures Using Hook Plate in Adult
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 20, 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
The aim of this current prospective study is to evaluate the effectiveness of an open reduction and internal fixation {ORIF} by distal ulna hooked locking compression plate (lcp) in treatment of isolated displaced distal ulna fracture in adult " without concomitant distal radius fractures.
Detailed Description
The distal ulna is an important component in the forearm and wrist motion. Pronation-supination is a complex movement, combining the rotation of the radius around the ulna with a horizontal and axial translation. If the distal ulna fails to heal in the proper anatomical position maintaining its original length with significant residual angulation at the fracture site, and separation of the DRUJ in a transverse axis, then a more severe limitation of forearm motion
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Ulna Fractures
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
adult patients with distal ulna fractures
Arm Type
Experimental
Arm Description
adult patients with distal ulna fractures
Intervention Type
Procedure
Intervention Name(s)
Hook plate
Other Intervention Name(s)
Distal ulna anatomical plate
Intervention Description
We used titanium 2.4 mm hooked distal ulnar locked plate used for fixation of distal ulna fractures , this plate have low profile which is anatomically precontoured
Primary Outcome Measure Information:
Title
Management of Distal Ulna Fractures Using Hook Plate
Description
surgery
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Skeletally mature distal ulna fracture with or without radius fracture.
Exclusion Criteria:
Pathological fracture Skeletally immaturity Neurovascular problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
salah roshdy ahmed, professor
Organizational Affiliation
Sohag University
Official's Role
Study Chair
Facility Information:
Facility Name
Sohag University
City
Sohag
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
• Patient still for 24 hours postoperative till discharge during this period follow up swelling and neurovascular complication and broad spectrum antibiotics will be taken.
Follow up of cases at 2weeks postoperative 1-3-6 months.
Learn more about this trial
Management of Distal Ulna Fractures Using Hook Plate
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