Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202401829673373 Date of Approval: 02/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Functional outcomes of Arthroscopic Assisted Fixation Versus open fixation of Greater Tuberosity humeral Fractures: A Randomized Controlled Trial
Official scientific title Functional outcomes of Arthroscopic Assisted Fixation Versus open fixation of Greater Tuberosity humeral Fractures: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Displaced greater tuberosity fractures of the humerus require anatomic reduction with stable fixation to optimize rotator cuff function and prevent sub-acromial impingement. A wide variety of surgical approaches and fixation constructs have been reported, largely with favorable results. Arthroscopic management of these fractures allows excellent visualization during fixation while minimizing soft tissue disruption, blood loss, and radiation exposure. Moreover, any displaced fracture of the greater tuberosity presents with a high rate of associated and largely undetected soft tissue lesions. The purpose of this study is to evaluate the clinical, radiographic and functional outcomes of treatment in patients with isolated greater tuberosity (GT) fractures of humerus using arthroscopic assisted technique together with evaluation and treatment of soft tissue lesions if present.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/09/2022
Actual trial start date 01/10/2022
Anticipated date of last follow up 01/02/2024
Actual Last follow-up date 01/03/2024
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
4920
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Arthroscopic Assisted Fixation of Greater Tuberosity Fractures one year patients will be lying in beach chair position then by using arthroscopy reduction of greater tuberosity fracture will be achieved then fixation by 4 mm cannulated screws together with addressing soft tissue concomitant injuries such as rotator cuff tears and labral injuries 15
Control Group open fixation of greater tuberosity humeral fractures one year open fixation of greater tuberosity humeral fractures 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Patients presenting with acute greater tuberosity fracture within three weeks from injury and diagnosed using plain X-ray and computed tomography.  Adult group (18-80) years.  Both genders  Open fracture or infected soft tissue.  Other accompanying proximal humerus fractures.  Patient of mal-united or delayed union fractures around the shoulder.  Uncontrolled diabetes mellitus or significant osteoporosis.  Elderly, and low-demand patients as bed ridden, paraplegic or quadriplegic patients  Patients who refuse to participate in the study. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/09/2022 research ethics committee
Ethics Committee Address
Street address City Postal code Country
ring road 4.5 km ismailia 41111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome achieving complete radiological union after three months then restoring normal daily activities in six months period then assessing the overall satisfaction after one year together with assessing any complications if present every visit the affected shoulder will be measured by Constant Murley score the outcomes will be measured after the intervention post operatively at time intervals of 2 weeks then 6 weeks then 3 months then 6 months then after a year
Secondary Outcome finding the incidence of soft tissue concomitant injuries related to greater tuberosity humeral fracture together with addressing any possible complications if present the lesions will be detected intraoperatively and addressed . the out comes will be measured after the intervention post operatively 2 weeks then 6 weeks then 3 months then 6 months then a year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez canal university hospitals ring road 4.5 km ismailia 41111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
suez canal university ring road 4.5 km ismailia 41111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine suez canal university hospital ring road 4.5 km ismailia 41111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries mahmoud elsherif elsherif_mahmoud@hotmail.com +201008765710 85 salah salem street
City Postal code Country Position/Affiliation
ismailia 41111 Egypt associate professor of orthopedic surgery
Role Name Email Phone Street address
Principal Investigator abdelrahman khaled bedoillusionist36@gmail.com +01000446207 207 elhoreya street
City Postal code Country Position/Affiliation
ismailia 41111 Egypt assistant lecturer of orthopedic surgery
Role Name Email Phone Street address
Scientific Enquiries tarek mahmoud tareksh64@yahoo.com +01119945343 el horeya street
City Postal code Country Position/Affiliation
ismailia 41111 Egypt professor of orthopedic surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data will be available that underlying the results reported in this article after de-identification (text,tables,figures and appendices) Informed Consent Form,Statistical Analysis Plan,Study Protocol one year this is a randomized controlled trial study conducted to assess the outcome of arthroscopic assisted fixation of greater tuberosity humeral fracture to any one who wish to access the data with data analysis for any purpose for (spss) 23 for windows program
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information