| CTRI Number |
CTRI/2026/02/104376 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing two different types of technique in wrist bone fractures |
|
Scientific Title of Study
|
A Comparitive Study between Plating vs 5 Pin technique in distal end radius fracture |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakthi kumaran A |
| Designation |
Junior resident, M.S orthopaedics |
| Affiliation |
SRM medical college and research centre |
| Address |
Department of orthopaedics, SRM medical college and research centre Chennai Tamil Nadu 603203
Chennai TAMIL NADU 603203 India |
| Phone |
09677066494 |
| Fax |
|
| Email |
sk3170@srmist.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Sabari Vaasan L |
| Designation |
Associate professor and unit chief,department of orthopaedics |
| Affiliation |
SRM medical college and research centre |
| Address |
Department of orthopaedics, SRM Medical college and research centre Chennai Tamil Nadu 603203
Chennai TAMIL NADU 603203 India |
| Phone |
8248201572 |
| Fax |
|
| Email |
sabarivl3170@srmist.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Sakthi kumaran A |
| Designation |
Junior resident, department of Orthopaedics |
| Affiliation |
SRM medical college and research centre |
| Address |
Department of orthopaedics, SRM Medical college and Research Centre Chennai Tamil Nadu 603203
Chennai TAMIL NADU 603203 India |
| Phone |
09677066494 |
| Fax |
|
| Email |
sk3170@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SAKTHI KUMARAN A |
| Address |
No14b Mahalakshmi Nagar 7th cross street, Adambakkam,Chennai-600093 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Sakthi Kumaran A |
SRM medical college and research centre |
Department of orthopaedics SRM medical college and research centre Chennai TAMILNADU 603203 Chennai TAMIL NADU |
09677066494
sk3170@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM medical college 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 |
kwire fixation |
for fracture fixation of distal end radius using 5kwires with duration of surgery 30 minutes |
| Comparator Agent |
plating |
fixation of distal end radius fracture through open reduction and internal fixation by plating with duration of surgery 120 minutes |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients age ( 20-60 years of age)
patients with distal radius fractures that are displaced intra- and extra – articular are included
in the study.
Open fracture grade 1and 2 |
|
| ExclusionCriteria |
| Details |
Patients with ipsilateral upper limb injuries
Patients with compound fractures ( grade 3)
Age less than 20 and more than 60
Pathological fractures
Patients with polytrauma with injury severity score greater than 16 points
Patients with pre-existing medical disorders that affect bone physiology like a malignant tumor, hyperparathyroidism, vascular insufficiency of the upper limb, alcoholic or drug dependency
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The activity level of the affected arm was assessed before and after surgery using DASH score or the Quick DASH score.
Quick DASH scoring AND MAYO SCORING
Radiological outcome:Radiological assessment was done in terms of residual dorsal angulation, radial shortening and loss of radial inclination and the results were graded according to the Lid Strom Criteria.
|
3months and 6months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess which has better functional and radiological outcome |
3months, 6 months |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
07/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="8" 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
|
This prospective randomized study compares functional and radiological outcomes of plating versus the 5-pin percutaneous technique for distal radius fractures. Sixty patients aged 20–60 years were evaluated using QuickDASH, Mayo scoring, and Lidstrom radiological criteria. The study examines operative time, complications, stability, and rehabilitation differences. Plating offers rigid fixation but carries risks such as longer surgery, blood loss, and hardware-related issues, while the 5-pin technique aims to maintain radial height with fewer complications and faster recovery. Results assess which method provides superior overall outcomes. |