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NCT Number: NCT06603428

Functional Outcome in Operative and Nonoperative Management in Isolated Greater Tuberosity Fracture of Humerus Bone

Constant score for functional outcome in operative and non-operative management in isolated greater tuberosity fractures of humerus bone.

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Key information

Conditions

Greater Tuberosity Fracture Fractures, Bone Shoulder Fractures Shoulder Injuries Wounds and Injuries

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kerolos Zaghlol Thabet

Asyut, Asyut Governorate, Egypt

About this study

Fractures of the greater tuberosity (GT) often occur with more complex proximal humerus fractures and are less frequently observed as an isolated pathology. Only 14-20% of proximal humerus fractures are isolated lesions of the GT. Up to 30% of these fractures are associated with anterior glenohumeral dislocations. According to Neer, a displacement of the fragment >5mm and 30°, or >3 mm of displacement in active patients involved in frequent overhead activity is believed to be an indication for operative treatment. However, indication for all other fractures had managed by nonoperative treatment is unclear. Currently, there is a lack of evidence in the literature to support either conservative or operative treatment strategies in GT humerus fractures. The fracture type and the etiology of the fracture impact the decision- making and the final outcome also remains unclear. age of more than 65 years as an important risk factor for secondary displacement in the conservative management of fractures of the greater tuberosity. Furthermore, fracture type and shoulder joint dislocations were factors associated with show increased relative risks for secondary fragment displacement.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

1-history of traumatic isolated GT fracture.

Exclusion criteria

1- associated proximal humeral fracture.

2 - previous shoulder pathology.

Treatment and study plan

internal fixation by plate or screws

Device

Patients more than 5 ml displacement of GT fracture (3ml in active highly demanded patient) are for internal fixation, others less this are for conservative management.

Other names: arthroscopic fixation of avulsion greater tuberosity fracture

Primary outcomes

Constant score for functional outcomes

Time frame: follow up 1 year
A-Pain (/15): Average(1+2) A
- Do you have pain in your shoulder (normal activities)? No =15 pts,Mild pain =10 pts,Moderate =5 pts,Severe or permanent =0.
- Linear scale:
If "0" means no pain and "15" is the maximum pain you can experience, please circle where is the level of pain of your shoulder.(Points given are inverse to the scale.E.g. level 5 in the scale means 10 points) B- Activities of daily living (/20) Total (1 + 2) B
- Is your occupation or daily living limited by your shoulder? No=4,Moderate limitation =2,Severe limitation=0
- Are your leisure and recreational activities limited by your shoulder? No=4,Moderate limitation = 2,Severe limitation=0 C.- Range of movement (leave this for the doctor or physiotherapist) (/40):Total (1 + 2 ) C
1.- FWD Flexion: 0-30 0 pts 2-Abduction: 0-30 D.- Power (/25): Points: average (kg) x 2= D

First pull:Second pull:Third pull:Fourth pull:Fifth pull:

Average pulls:

TOTA

Study contacts

Contact information is provided by the study sponsor or research team.

Kerolos Z Thabet, master

CONTACT

[email protected]

01096271767

hesham A kady, prof

CONTACT

[email protected]

01005211797

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Functional Outcome in Operative and Nonoperative Management in Isolated Greater Tuberosity Fracture of Humerus Bone: (cohort Study)

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Sep 19, 2024
Registry last updated: Sep 19, 2024

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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