| CTRI Number |
CTRI/2024/09/073352 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of threaded k wire fixation for distal end radius fracture in osteoporotic bone |
|
Scientific Title of Study
|
Outcome of Distal end radius fracture treated with Threaded K wire fixation in osteoporotic bone |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KAUSTAV DATTA |
| Designation |
Junior resident |
| Affiliation |
Datta Meghe Institue of higher education and research |
| Address |
Department of Orthopaedics, Jawaharlal Nehru Medical College Sawangi (Meghe), Wardha, Maharastra, 442001
Wardha
MAHARASHTRA
442107
India |
| Phone |
9786698220 |
| Fax |
|
| Email |
kaustavdatta92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NITIN N SAMAL |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of higher education and research |
| Address |
Department of orthopaedics, Jawaharlal Nehru Medical College,
Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442107
India |
| Phone |
8888244448 |
| Fax |
|
| Email |
nitinsamal2486@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kaustav Datta |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of higher education and research |
| Address |
Department of orthopaedics, Jawaharlal Nehru Medical College,
Sawangi (Meghe), Wardha, Maharashtra, 442001, India
Wardha
MAHARASHTRA
442107
India |
| Phone |
8888244448 |
| Fax |
|
| Email |
kaustavdatta92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Orthopaedics Department, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha,
Maharashtra 442001 |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
NONE |
| Type of Sponsor |
Other [NONE] |
|
|
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 Kaustav Datta |
Jawaharlal Nehru Medical College |
Department of
Orthopaedics,
Sawangi(Meghe),
Wardha, Maharashtra
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA |
9786698220
kaustavdatta92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DMIHER INSTITUTIONAL ETHICS COMITEE |
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, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CLOSED REDUCTION AND INTERNAL FIXATION WITH THREADED K WIRE FOR DISTAL END RADIUS FRACTURE |
PATIENT HAVING DISTAL END RADIUS FRACTURE WILL BE ASSESSED CLINICALLY AND RADIOLOGICALLY. CONSENTING PATIENT TO BE TREATED WITH THREADED K WIRE.
FOLLOW UP TO BE DONE AT 3 DAYS, 2 WEEKS, 6 WEEKS, 3 MONTHS AND 6 MONTHS
|
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 years and above
Fracture of distal end radius reporting with in 3 weeks
Predominantly extraarticular fracture and undisplayed intraarticular fracture of distal end radius |
|
| ExclusionCriteria |
| Details |
Neurovascular involvement
Comprised of skeletal immaturity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To analyse outcome of fractures of distal end radius
treated with fixation with Kirschner
wire in osteoporotic bone |
AT 3 days,
AT 2 weeks,
At 1 ½ month,
At 3 month,
At 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcomes of the study includes
analysis of fractures of Distal end radius in terms of
1) Radiological outcome
2) Functional outcome |
AT 3 days,
AT 2 weeks,
AT 1 ½ month,
AT 3 month,
AT 6 months |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
08/09/2024 |
| 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 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
|
Patients coming to AVBRH department of Orthopaedics will be examined clinically and radiographic evaluation of wrist Antero-posterior and lateral will be done. The patients diagnosed with having distal end radius fracture will be selected. Based on the inclusion and exclusion criteria, the selected patients for the study will be subjected to a proforma. Consents will be obtained from the selected study subjects. The consenting individuals will then be investigated based on routine investigations like CBC, KFT, LFT, RBS and PT-INR. Once the routine investivagtions are within normal range, the patients will either be managed with closed reduction and threaded k-wires fixation for distal end radius fracture. Closed reduction and threaded K-wire fixation will be carried out in patients consenting for the study. The patients will then be followed up at 3 days, 2 weeks, 6 weeks, 3 months and 6 months to evaluate the functional outcomes |