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CTRI Number  CTRI/2025/11/097497 [Registered on: 17/11/2025] Trial Registered Prospectively
Last Modified On: 16/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   A study comparing multilock nail and proximal humerus locking plate fixation for proximal humerus fractures. 
Scientific Title of Study   Functional and radiological comparison of multilock nail and proximal humerus locking plate in proximal humerus fractures: A randomized study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sathyanand V 
Designation  doctor 
Affiliation  SRM Medical College Hospital and Research Centre 
Address  Department of Orthopaedics SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Chengalpattu, Tamil Nadu - 603203
Dr.Dilip Kumar Department of Orthopaedics SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Chengalpattu, Tamil Nadu - 603203
Chennai
TAMIL NADU
603203
India 
Phone  9566992940  
Fax    
Email  sv6864@srmist.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sathyanand V 
Designation  PG student 
Affiliation  SRM Medical College Hospital and Research Centre 
Address  Department of Orthopaedics SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Chengalpattu, Tamil Nadu - 603203
Dr.Dilip Kumar Department of Orthopaedics SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Chengalpattu, Tamil Nadu - 603203
Chennai
TAMIL NADU
603203
India 
Phone  9566992940  
Fax    
Email  sv6864@srmist.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sathyanand V 
Designation  PG student 
Affiliation  SRM Medical College Hospital and Research Centre 
Address  Department of Orthopaedics SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Chengalpattu, Tamil Nadu - 603203
Department of Orthopaedics SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Chengalpattu, Tamil Nadu - 603203
Chennai
TAMIL NADU
603203
India 
Phone  9566992940  
Fax    
Email  sv6864@srmist.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Department of Orthopaedics SRM Medical College Hospital and Research Centre 
Address  Department of Orthopaedics SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Chengalpattu, Tamil Nadu - 603203 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sathyanand V  SRM Medical College Hospital and Research Centre  Department of Orthopaedics, SRM Medical College Hospital & Research Centre, SRM Nagar, Potheri, Kattankulathur, Chengalpattu District, Tamil Nadu – 603203
Chennai
TAMIL NADU 
9566992940

sv6864@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee – Students, SRM Medical College Hospital and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S422||Fracture of upper end of humerus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multilock Intramedullary Nail Fixation  Surgical fixation of proximal humerus fractures using multilock intramedullary nailing system as per standard orthopaedic surgical protocol. 
Comparator Agent  Proximal Humerus Locking Plate Fixation  Surgical fixation of proximal humerus fractures using proximal humerus locking plate (PHILOS) as per standard operative technique. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Age 18 years - 65 YRS
2)NEER 2, 3, 4 part Proximal Humerus Fracture
3)Normal pre-injury shoulder function 
 
ExclusionCriteria 
Details  1)Head split fractures, fracture dislocation
2)Neurovascular injury(Brachial plexus injury -flail arm)
3)Chronic shoulder pain or prior surgery
4)Systemic infections
5)Poorly controlled hypertension or diabetes
6)Pathological fracture 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Functional outcome measured using ASES Score, QuickDASH Score, and Visual Analog Scale (VAS) at 2 weeks, 1 month, 3 months and 6 months  Functional outcome measured using ASES Score, QuickDASH Score, and Visual Analog Scale (VAS) at 2 weeks, 1 month, 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Neck-Shaft Angle (NSA).  Immediate postoperative period, 3 months, and 6 months. 
Radiological assessment of fracture union.  At 6 weeks, 3 months, and 6 months.
 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   04/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Proximal humerus fractures are common injuries in adults and their management remains challenging due to variation in fracture patterns and bone quality. Surgical fixation is often preferred to restore shoulder function and prevent long term disability. Two commonly used fixation methods are the Multilock intramedullary nail and the Proximal Humerus Locking Plate. Previous studies have shown differing results regarding functional recovery, radiological healing, and complication rates between these two implants. The Multilock nail represents the latest generation of intramedullary devices with improved biomechanics and reduced soft tissue damage.


This prospective randomized comparative study aims to evaluate and compare the functional and radiological outcomes of Multilock nail fixation versus Proximal Humerus Locking Plate fixation in patients with proximal humerus fractures. A total of sixty four patients will be included and randomized into two groups. Functional outcome will be assessed using Visual Analog Score, ASES score, and QuickDASH score. Radiological outcomes will include time to union and changes in neck shaft angle. Complications such as infection, implant failure, malunion, and shoulder stiffness will also be recorded.


The study will help determine which surgical method provides better clinical outcomes and may guide surgeons in selecting the appropriate fixation method for proximal humerus fractures.

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