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Completed

NCT Number: NCT04995744

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

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SBU Prof. Cemil Tascioglu City Hospital

Istanbul, 34040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pectoralis Major Pedicle Bone Graft

Procedure

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 outcomes

  1. Patients were evaluated in terms of functional shoulder results and radiographic union

    Time frame: 2 years

    Constant and American shoulder and elbow surgeons scores were used for functional assesment

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 9, 2021
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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