Pectoralis Major Pedicle Bone Graft For 4-Part Proximal Humerus Fractures

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization (Other)

Overall Status

Completed

CT.gov ID

NCT04995744

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Patients With Closed Neer Type 4 Proximal Humerus Fractures	Procedure: Pectoralis Major Pedicle Bone Graft	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pectoralis Major Pedicle Bone Graft For 4-Part Proximal Humerus Fractures

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jan 30, 2020

Actual Study Completion Date :

Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients with closed Neer type 4 proximal humerus fractures patients aged 50-75 years with closed Neer type 4 proximal humerus fractures	Procedure: Pectoralis Major Pedicle Bone Graft 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.

Arm

Intervention/Treatment

Other: Patients with closed Neer type 4 proximal humerus fractures

patients aged 50-75 years with closed Neer type 4 proximal humerus fractures

Procedure: Pectoralis Major Pedicle Bone Graft

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.

Outcome Measures

Primary Outcome Measures

Patients were evaluated in terms of functional shoulder results and radiographic union [2 years]
Constant and American shoulder and elbow surgeons scores were used for functional assesment

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SBU Prof. Cemil Tascioglu City Hospital	Istanbul		Turkey	34040

Sponsors and Collaborators

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Fialka C, Stampfl P, Arbes S, Reuter P, Oberleitner G, Vécsei V. Primary hemiarthroplasty in four-part fractures of the proximal humerus: randomized trial of two different implant systems. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):210-5. Epub 2007 Oct 10.

Responsible Party:

Bulent KARSLIOGLU, Orthopedics and Traumatology specialist, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

ClinicalTrials.gov Identifier:

NCT04995744

Other Study ID Numbers:

Pectoralis Major Pedicle Graft

First Posted:

Aug 9, 2021

Last Update Posted:

Aug 9, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bulent KARSLIOGLU, Orthopedics and Traumatology specialist, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Additional relevant MeSH terms:

Fractures, Bone

Humeral Fractures

Study Results

No Results Posted as of Aug 9, 2021