| CTRI Number |
CTRI/2026/01/100550 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Two Common Plaster Methods for Wrist Fractures: Full Cast vs Two Splints in Adults |
|
Scientific Title of Study
|
Comparison of outcomes of distal radius fractures treated by circumferential casting versus dual splinting |
| 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 Hemant More |
| Designation |
Associate Professor |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak, Haryana |
| Address |
Department of Orthopaedics, Pt B D Sharma PGIMS Rohtak,
Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9467007676 |
| Fax |
|
| Email |
drmore@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil |
| Designation |
MS Post Graduation Student |
| Affiliation |
Pt B D Sharma PGIMS Rohtak, Haryana |
| Address |
Department of Orthopaedics, Pt B D Sharma PGIMS Rohtak,
Haryana
Rohtak
HARYANA
124001
India |
| Phone |
8929236928 |
| Fax |
|
| Email |
aniltheprince7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil |
| Designation |
MS Post Graduation Student |
| Affiliation |
Pt B D Sharma PGIMS Rohtak, Haryana |
| Address |
Department of Orthopaedics, Pt B D Sharma PGIMS Rohtak,
Haryana
HARYANA
124001
India |
| Phone |
8929236928 |
| Fax |
|
| Email |
aniltheprince7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt B D Sharma PGIMS Rohtak, Haryana, India ,Pin code :- 124001 |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma PGIMS Rohtak |
| Address |
Pt B D Sharma PGIMS Rohtak, Haryana, India , Pin Code :- 124001 |
| Type of Sponsor |
Government 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 Anil |
Pt B D Sharma PGIMS Rohtak |
Department of
Orthopaedics, Pt B D
Sharma PGIMS
Rohtak, Haryana, India
Rohtak
HARYANA |
8929236928
aniltheprince7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S525||Fracture of lower end of radius, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Circumferential casting |
Patients with distal end radius fracture are treated with circumferential casting and asked to follow up |
| Comparator Agent |
Dual Splinting |
Patients with distal end radius fracture are treated with dual slpinting and asked to follow up |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have closed extraarticular distal end radius fracture |
|
| ExclusionCriteria |
| Details |
1. Patients with intra articular fractures, neuro vascular injuries, open fractures and skin lesions will be excluded
2. Patients who opt out at any stage
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess which type of immobilisation, a dual splint versus a circumferential cast, is more optimal to prevent fracture redisplacement in adult patients with a reduced Distal end Radius fracture. |
Assessment to be done at baseline, 1 week, 2 weeks, 4 weeks and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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
|
Any patient above 18 years of age presenting to OPD/emergency of PGIMS, Rohtak with distal end radius fracture and willing to participate in the study will be included. After informed consent relevant examination will be done. Xray of distal end radius will be done which is the part of investigation and treatment. Patient treated with either circumferential casting or dual splinting on randomization and asked for regular follow up in OPD. Study is aimed to compare outcomes of distal end radius fractures treated by circumferential casting versus dual splinting and to assess which outcome has fewer complications. |