Pectoralis Major Pedicle Bone Graft For 4-Part Proximal Humerus Fractures
Primary Purpose
Patients With Closed Neer Type 4 Proximal Humerus Fractures
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pectoralis Major Pedicle Bone Graft
Sponsored by
About this trial
This is an interventional treatment trial for Patients With Closed Neer Type 4 Proximal Humerus Fractures focused on measuring proximal humerus, closed, fracture, bone pedicled graft
Eligibility Criteria
Inclusion Criteria:
- patients aged 50-75 years with closed Neer type 4 proximal humerus fractures
Exclusion Criteria:
- Patients under 50 and over 75 years of age,
- Patients with pathological fractures,
- Patients with neurological deficits such as brachial plexus injury
- Patients with previous shoulder surgery
Sites / Locations
- SBU Prof. Cemil Tascioglu City Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with closed Neer type 4 proximal humerus fractures
Arm Description
patients aged 50-75 years with closed Neer type 4 proximal humerus fractures
Outcomes
Primary Outcome Measures
Patients were evaluated in terms of functional shoulder results and radiographic union
Constant and American shoulder and elbow surgeons scores were used for functional assesment
Secondary Outcome Measures
Full Information
NCT ID
NCT04995744
First Posted
July 30, 2021
Last Updated
July 30, 2021
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
1. Study Identification
Unique Protocol Identification Number
NCT04995744
Brief Title
Pectoralis Major Pedicle Bone Graft For 4-Part Proximal Humerus Fractures
Official Title
Pectoralis Major Pedicle Bone Graft For 4-Part Proximal Humerus Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
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 investigators tried to evaluate the results of our patients who underwent plate osteosynthesis with vascularized pectoralis major graft for the treatment of 4-part proximal humerus fractures.
Detailed Description
The risk of avascular necrosis, nonunion, or malunion is high in 4-part fractures which is the most serious form of proximal humerus fracture.Bone impaction grafts are an important treatment option when osteosynthesis with LCP plate is desired especially for osteoporotic patients. Fibular strut grafts (FSGs) and autologous iliac bone impaction grafts (AIBIGs), which are frequently used to provide mechanical support, may have the risk of nonunion in osteoporotic bone whose vascular support is weakened due to fracture. Bone pedicled pectoralis major grafts may prevent varus collapse, nonunion and avascular necrosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Closed Neer Type 4 Proximal Humerus Fractures
Keywords
proximal humerus, closed, fracture, bone pedicled graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with closed Neer type 4 proximal humerus fractures
Arm Type
Other
Arm Description
patients aged 50-75 years with closed Neer type 4 proximal humerus fractures
Intervention Type
Procedure
Intervention Name(s)
Pectoralis Major Pedicle Bone Graft
Intervention Description
It is aimed to restore the integrity of the medial cortex with the bone pedicle from the insertion region of the pectoralis major muscle in middle-aged patients with Neer type 4 proximal humerus fractures. Researchers aim to reduce the risk of avascular necrosis with a vascular living bone tissue, as well as providing mechanical support with this method. The investigators aim to reduce the risk of avascular necrosis with a vascular living bone tissue, as well as providing mechanical support with this method.
Primary Outcome Measure Information:
Title
Patients were evaluated in terms of functional shoulder results and radiographic union
Description
Constant and American shoulder and elbow surgeons scores were used for functional assesment
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients aged 50-75 years with closed Neer type 4 proximal humerus fractures
Exclusion Criteria:
Patients under 50 and over 75 years of age,
Patients with pathological fractures,
Patients with neurological deficits such as brachial plexus injury
Patients with previous shoulder surgery
Facility Information:
Facility Name
SBU Prof. Cemil Tascioglu City Hospital
City
Istanbul
ZIP/Postal Code
34040
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Learn more about this trial
Pectoralis Major Pedicle Bone Graft For 4-Part Proximal Humerus Fractures
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