| CTRI Number |
CTRI/2024/05/067465 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
12/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparative analysis of percutaneous K-wire fixation versus cast immobilization for distal radius fracture in elderly
|
|
Scientific Title of Study
|
Comparative analysis of percutaneous K-wire fixation versus cast immobilization for distal radius fracture in elderly
|
| 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 Ankit Vashisth |
| Designation |
junior resident |
| Affiliation |
PGIMS, Rohtak |
| Address |
orthopedics department, PGIMS
Rohtak
HARYANA
124001
India |
| Phone |
8708907911 |
| Fax |
|
| Email |
avavashist@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Kamboj |
| Designation |
Senior Professor |
| Affiliation |
PGIMS, Rohtak |
| Address |
Dr Pradeep Kamboj Senior Professor department of Orthopedics PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9992014147 |
| Fax |
|
| Email |
kambojdr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankit Vashisth |
| Designation |
junior resident |
| Affiliation |
PGIMS, Rohtak |
| Address |
orthopedics department PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8708907911 |
| Fax |
|
| Email |
avavashist@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt BD Sharma PGIMS, Rohtak,124001, India |
|
|
Primary Sponsor
|
| Name |
Dr Ankit Vashisth |
| Address |
hs no 419 2nd floor omaxe city phase 2 sector 26, ROHTAK, 124001, India |
| 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 Ankit VAshisth |
Pt BD Sharma PGIMS |
Department of Orthopedics, PGIMS, 124001 Rohtak
Rohtak
HARYANA |
8708907911
avavashist@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, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cast immobilization of fracture distal end of radius in elderly patients . |
Cast immobilization of fracture distal end of radius in elderly patients with age more than 60 yrs with extraarticular fractures |
| Intervention |
Percutaneous K wire fixation of fracture distal end of radius in elderly |
Percutaneous K wire fixation of fracture distal end of radius in elderly patients with age more than 60 yrs with extraarticular fractures |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Elderly Patients with fracture distal end of radius with age more than 60 years and extraarticular fractures |
|
| ExclusionCriteria |
| Details |
1. Intra articular fracture
2. Open fractures
3. Any previous wrist pathology |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified Cooneys score measuring pain, range of motion, Functional status |
pain, range of motion and functional status will be measured at 8 weeks and 16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate complications if any |
To evaluate complications if any at the end of 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 |
|
Date of First Enrollment (India)
|
23/05/2024 |
| 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="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
|
Comparative analysis of percutaneous K-wire fixation versus cast immobilization for distal radius fracture in elderly AIM To compare and analyze percutaneous K-wire fixation versus cast immobilization for distal radius fracture in elderly. OBJECTIVES Primary Objective 1. To analyze and compare the clinical and radiological outcome of cast immobilization and percutaneous pinning in distal radius fracture among elderly. Secondary objective 1. To evaluate complications if any 2. To evaluate the role of percutaneous pinning as day care procedure.
|