| CTRI Number |
CTRI/2024/11/077187 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Functional and Radiological outcome of Colles fracture treated with plaster application after hematoma block in patients aged more than 40 years. |
|
Scientific Title of Study
|
Functional and radiological outcome of Colles fracture treated by closed reduction and cast application using hematoma block. |
| 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 Rahul Kar |
| Designation |
Postgraduate trainee, Department of Orthopaedics, AIIMS Guwahati, Changsari, Assam. |
| Affiliation |
All India Institute of Medical Sciences(AIIMS),Guwahati,Chansari,Assaam. |
| Address |
Department of orthopaedics,
AIIMS Guwahati,
Changsari, Assam, 781101.
Kamrup
ASSAM
781101
India |
| Phone |
8509123435 |
| Fax |
|
| Email |
rahul1998kar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharan Mallya P |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
All India Institute of Medical Sciences AIIMS - Guwahati |
| Address |
Department of orthopaedics,
AIIMS Guwahati,
Changsari, Assam, 781101.
Department of orthopaedics,
AIIMS Guwahati,
Changsari, Assam, 781101.
Kamrup
ASSAM
781101
India |
| Phone |
9901771260 |
| Fax |
|
| Email |
sharanmallya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharan Mallya P |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
All India Institute of Medical Sciences AIIMS - Guwahati |
| Address |
Department of orthopaedics,
AIIMS Guwahati,
Changsari, Assam, 781101.
Department of orthopaedics,
AIIMS Guwahati,
Changsari, Assam, 781101.
Kamrup
ASSAM
781101
India |
| Phone |
9901771260 |
| Fax |
|
| Email |
sharanmallya@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES GUWAHATI
CHANGSARI,ASSAM.
PIN-781101. |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences,Guwahati,Assam. |
| Address |
Changsari,Assam,PIN-781101. |
| 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 Rahul Kar |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES GUWAHATI,CHANGSARI,ASSAM PIN-781101.. |
Out Patient Department(OPD) of Department of Orthopaedics and Trauma centre of Trauma and Emergency department , AIIMS Guwahati,Changsari,Assam.
Kamrup
ASSAM |
8509123435
rahul1998kar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,AIIMS Guwahati. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M998||Other biomechanical lesions, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient aged 40 years and above.
2.Patient diagnosed with Colles fracture, which is confirmed by clinical examination and radiological examination. |
|
| ExclusionCriteria |
| Details |
1.Previous wrist injuries or surgeries affecting the affected limb.
2.Distal radius fracture with interarticular extension seen in radiographs.
3.Polytrauma patient with concomitant injuries requiring surgical interventions.
4.Patients with contraindications to hematoma block, such as allergy to local anaesthetic, coagulopathy, or infection at the injection site. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
FUNCTIONAL OUTCOMES:
IMPROVEMENT IN RANGE OF MOTION OF THE AFFECTED WRIST JOINT COMPARED TO PRE-OPERATIVE MEASUREMENTS.
INCREASE IN GRIP STRENGTH AS MEASURED BY A DYNAMOMETRE POSTOPERATIVELY.
MAYO WRIST SCORE IS CALCULATED TO INTERPRET OUTCOMES.
ENHANCED PATIENT -REPORTED OUTCOMES, INCLUDING DECREASED PAIN LEVELS AND IMPROVED ABILITY TO PERFORM ACTIVITIES OF DAILY LIVING.
RADIOLOGICAL OUTCOMES: GRAHAM,S CRITERIA IS USED WHICH ACCOUNTS RADIAL TILT,RADIAL INCLINITION,RADIAL LENGTH AND ARTERIAL INCONGRUITY.
ABSENCE OF SECONDARY DISPLACEMENT OR LOSS OF REDUCTION DURING THE FOLLOW-UP PERIOD,INDICATING FRACTURE STABILITY AND SUCCESSFUL HEALING. |
DAY-0 (PRE AND POST-REDUCTION VISIT) OF HOSPITAL VISIT,1ST WEEK, 4TH WEEK AND 6 WEEKS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To enumerate the complications during the course of treatment. |
During the course of treatment at any point of time. |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
28/11/2024 |
| 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="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
|
The main goal of the study is to assess the functional and radiological outcome of Colles fracture treated with closed reduction and cast application using hematoma block and also to enumerate the complications found during the course of the treatment. There are multiple modalities of reduction technique for Colles fracture but noticeable gap in the literature regarding the use of hematoma block as an adjuvant technique in Closed reduction and can application for colles fracture. This study is focusing on the patient diagnosed with colles fracture of age 40 years and above. |