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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Greater Tuberosity Fracture
• Intervention / Treatment: Device: internal fixation by plate or screws

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kerolos Z Thabet, master; Phone Number: 01096271767; Email: KerolosZaghloul@med.nvu.edu.eg
• Study Contact Backup: Name: hesham A kady, prof; Phone Number: 01005211797; Email: heshamelkady9919@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Kerolos Zaghlol Thabet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1-history of traumatic isolated GT fracture.

Exclusion Criteria:

- 1- associated proximal humeral fracture.

2 - previous shoulder pathology.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Operative and Nonoperative Management in Isolated Greater Tuberosity Fracture of Humerus Bone.; 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.	Device: internal fixation by plate or screws; - 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant score for functional outcomes	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	follow up 1 year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Kerolos Z Thabet, master, Assiut University

Publications and helpful links

General Publications

• Schliemann B, Heilmann LF, Raschke MJ, Lill H, Katthagen JC, Ellwein A. Isolated fractures of the greater tuberosity: When are they treated conservatively?: A baseline study. Obere Extrem. 2018;13(2):106-111. doi: 10.1007/s11678-018-0459-z. Epub 2018 May 15.

Study record dates

Study Major Dates

• Study Start (Estimated): October 10, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: greater tuberosity fracture

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

For conservative cases

• 1ist 4 weeks abduction sling.
• 2end 2 weeks active assisted movement + abduction sling.
• After 6 weeks active movement. For operative cases
• Day one passive movement.
• After 4 weeks active assisted movement.
• After 6 weeks active movement

• IPD Sharing Time Frame: Follow up conservative and operative cases for one year, radiological assessment by x-ray and clinical assessment follow up at 1.5,3,6,9 month and at 1 year using Constant score
• IPD Sharing Access Criteria: isolated GT fracture; age 20-60
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• 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