| 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
|
|
|
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
|
|
|
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
|
|
|
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 |
|
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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. I |