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

NCT06603428 | Not Yet Recruiting DMC

• 1 other identifier: greater tuberosity fracture
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Greater Tuberosity Fracture

Outcome Measures

Primary Outcomes (1)

• Constant score for functional outcomes

  A-Pain (/15): Average(1+2) A 1. Do you have pain in your shoulder (normal activities)? No =15 pts,Mild pain =10 pts,Moderate =5 pts,Severe or permanent =0. 2. 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 1. Is your occupation or daily living limited by your shoulder? No=4,Moderate limitation =2,Severe limitation=0 2. 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

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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.

Also known as: arthroscopic fixation of avulsion greater tuberosity fracture

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

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• history of traumatic isolated GT fracture.

You may not qualify if:

• \- 1- associated proximal humeral fracture.
• previous shoulder pathology.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Kerolos Zaghlol Thabet

Asyut, Asyut Governorate, Egypt

Location

Related Publications (1)

• 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.

  PMID: 29887916 BACKGROUND

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Study Officials

• Kerolos Z Thabet, master

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerolos Z Thabet, master

CONTACT

01096271767; KerolosZaghloul@med.nvu.edu.eg

hesham A kady, prof

CONTACT

01005211797; heshamelkady9919@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asisstant lecturer

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: October 10, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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
• Access Criteria: 1. isolated GT fracture 2. age 20-60

Locations

EG (1)