| CTRI Number |
CTRI/2025/03/082048 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
K-wire vs Plate fixation for proximal humerus fractures in the elderly |
|
Scientific Title of Study
|
J-Nailing vs Plate Osteosynthesis for proximal Humerus fractures in the elderly - An interventional 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 |
Dr Abraham Aleyas |
| Designation |
Post graduate |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
G Block, 2nd floor, SRM Medical College Hospital and Research Centre,
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9620185236 |
| Fax |
|
| Email |
aa7144@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR E Dilip Kumar Naidu |
| Designation |
Professor ( Department of Orthopaedics) |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Department of Orthopaedics, SRM Medical College Hospital and Research Centre, Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
9884460536 |
| Fax |
|
| Email |
erraguntladilipnaidu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR E Dilip Kumar Naidu |
| Designation |
Professor ( Department of Orthopaedics) |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Department of Orthopaedics, SRM Medical College Hospital and Research Centre, Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
9884460536 |
| Fax |
|
| Email |
erraguntladilipnaidu@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM INSTITUTE OF SCIENCE AND TECHNOLOGY,
SRM Medical College Hospital and Research Centre,
Kattankulathur,
TamilNadu - 603203 |
|
|
Primary Sponsor
|
| Name |
SRM Medical College Hospital and Research Centre |
| Address |
G Block, 2nd floor, Department of Orthopaedics, SRM Medical College Hospital and Research Centre, Kattankulathur, Kanchipuram - 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 Abraham Aleyas |
SRM Medical College Hospital and Research Centre |
G2/11 block, 2nd floor, SRM Medical College Hospital and Research Centre, Kattankulathur - 603203
Kancheepuram
TAMIL NADU |
9620185236
aa7144@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
J-Nailing |
Percutaneous K-wire fixation using J wire technique using 2-3 K-wire or TENS nail
Surgery duration: 60-90 minutes |
| Comparator Agent |
Plate Osteosynthesis |
Proximal Humerus Open reduction and Internal fixation using proximal humerual locking plate system
Surgery duration : 90 - 120 minutes |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Elderly aged above 60 years,
Closed unstable proximal humerus fractures (2 part, 3 part, 4 part according to Neers classification),
Presenting within 4 weeks of injury
No neurovascular deficit |
|
| ExclusionCriteria |
| Details |
Compound fractures,
Pathological fractures,
Patients with fracture dislocation,
Polytrauma patients,
Patients with previous history of shoulder fracture and shoulder surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Constant Murley Score:
Pain score, shoulder function - movements : Abduction, Flexion, external rotation and internal rotation, activities of daily loving affected and strength |
1 month, 6 months, 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
VAS score system for pain
Radiological assessment for healing, callus formation and union time
Complications |
1 month, 6 months, 1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
24/03/2025 |
| 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 Applicable |
| 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
|
This prospective randomized controlled trial will be conducted at the Department of Orthopaedics, SRMCH&RC. The study will include patients over the age of 60 years with closed unstable proximal humeral fractures, classified as 2-Part, 3-Part, or 4-Part according to Neer’s Classification. Patients are excluded if they present with neurovascular deficits or if they have fractures with additional complicating factors. A total of 60 patients will be included in the study, with 30 patients randomly assigned to Group A (J nailing) and 30 patients to Group B (PHILOS plating). Demographic data, including age, gender and comorbidities will be collected, and both groups will be monitored for functional outcomes using the Constant-Murley Score at baseline and at 24 months post-surgery as the primary Outcome. Secondary outcomes include VAS score, radiological assessment like time to union and complications. Other parameters, such as duration of surgery and intraoperative blood loss, will also be recorded. The Chi-square test, Z-test, and p-values will be used for statistical analysis.
|