Back to resultsModified Hook Wiring Technique for Greater Tuberosity Fractures, a Prospective Study
Primary Purpose
Greater Tuberosity Fractures
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
fixation of greater tuberosity fractures
Sponsored by
About this trial
This is an interventional treatment trial for Greater Tuberosity Fractures
Eligibility Criteria
Inclusion Criteria:
Patients presented and admitted at Mansoura Trauma, emergency hospital affiliated to Mansoura university, with acute isolated displaced GT fractures ( more than 5mm displacement), with/without glenohumeral dislocations, with age between 18years to 50 years.
Exclusion Criteria:
- Skeletally immature patients (less than 18 years), age more than 50 years.
- Open and pathological fractures
- Associated proximal humeral fractures
- History of previous GH dislocations
- History of previous shoulder injuries or surgeries
Sites / Locations
- Mansoura university hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cases undergoing fixation of fractured greater tuberosity
Arm Description
Outcomes
Primary Outcome Measures
functional outcome using American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment score
postoperative assessing pain, range of motion, function of shoulder. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition
Secondary Outcome Measures
healing time
estimate time till radiological healing on follow-up radiographs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05403879
Brief Title
Modified Hook Wiring Technique for Greater Tuberosity Fractures, a Prospective Study
Official Title
Modified Hook Wiring Technique for Greater Tuberosity Fractures, a Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 23, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
the purpose of this study is to assess functional and radiological outcome of open reduction and internal fixation of isolated displaced greater tuberosity fractures (more than 5mm displacement) in adults advocating modified hook wiring with a follow-up period of one year.
Detailed Description
after being informed about the study and potential risks, all enrolled cases giving informed consent will undergo fixation of their fractured greater tuberosity, then physiotherapy. patients will be followed up till full union, clinical and radiological follow up for at least one year utilizing approved clinical scores and radiological criteria for healing. any complication will be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Greater Tuberosity 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
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cases undergoing fixation of fractured greater tuberosity
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
fixation of greater tuberosity fractures
Intervention Description
deltopectoral approach for shoulder, then open reduction and fixation of displaced greater tuberosity fractures using hooked Kirshner wires
Primary Outcome Measure Information:
Title
functional outcome using American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment score
Description
postoperative assessing pain, range of motion, function of shoulder. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition
Time Frame
at least one year follow up
Secondary Outcome Measure Information:
Title
healing time
Description
estimate time till radiological healing on follow-up radiographs
Time Frame
anticipated 2-4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients presented and admitted at Mansoura Trauma, emergency hospital affiliated to Mansoura university, with acute isolated displaced GT fractures ( more than 5mm displacement), with/without glenohumeral dislocations, with age between 18years to 50 years.
Exclusion Criteria:
Skeletally immature patients (less than 18 years), age more than 50 years.
Open and pathological fractures
Associated proximal humeral fractures
History of previous GH dislocations
History of previous shoulder injuries or surgeries
Facility Information:
Facility Name
Mansoura university hospital
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt
12. IPD Sharing Statement
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Modified Hook Wiring Technique for Greater Tuberosity Fractures, a Prospective Study
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