| CTRI Number |
CTRI/2024/06/068861 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In cases of Transverse Patellar Fractures, a comparison of surgery using Screws vs Wires |
|
Scientific Title of Study
|
Comparison of radiological and functional outcomes of transverse patellar fractures fixed with tension band fixation using cannulated screws and kirschner wires |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rishav Chakraborty |
| Designation |
Post graduate trainee |
| Affiliation |
Institute of post graduate medical education and research |
| Address |
Department of orthopaedics, Institute of post graduate medical education and research, 244 A.J.C. Bose road, Kolkata 700020
498, Mahatma Gandhi Road, Thakurpukur, KOLKATA - 700063
Kolkata
WEST BENGAL
700020
India |
| Phone |
9163767111 |
| Fax |
|
| Email |
chakrabortyrishav111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Tanmay Datta |
| Designation |
Professor |
| Affiliation |
Institute of post graduate medical education and research |
| Address |
Department of orthopaedics, Institute of post graduate medical education and research, 244 A.J.C. Bose road, Kolkata 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433012422 |
| Fax |
|
| Email |
tanmayortho@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Tanmay Datta |
| Designation |
Professor |
| Affiliation |
Institute of post graduate medical education and research |
| Address |
Department of orthopaedics, Institute of post graduate medical education and research, 244 A.J.C. Bose road, Kolkata 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433012422 |
| Fax |
|
| Email |
tanmayortho@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of orthopaedics, Institute of post graduate medical education and research, 244, A.J.C. Bose road, Kolkata, West Bengal, India PIN - 700020 |
|
|
Primary Sponsor
|
| Name |
Department of orthopaedics Institute of post graduate medical education and research |
| Address |
244, A.J.C. Bose road, Kolkata, West Bengal, India PIN - 700020 |
| 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 Rishav Chakraborty |
Institute of post graduate medical education and research |
Department of orthopaedics,244, A.J.C. Bose road, Kolkata 700020
Kolkata
WEST BENGAL |
9163767111
chakrabortyrishav111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER RESEARCH OVERSIGHT 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 |
Cannulated screw group |
Open reduction and internal fixation surgery of transverse patellar fractures to be done with Tension band wiring using two four mm cannulated screws. Duration of intervention one hour. |
| Comparator Agent |
Kirschner wire group |
Open reduction and internal fixation surgery of transverse patellar fractures to be done with Tension band wiring using two Kirschner wires. Duration of intervention one hour. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients above 18 years of age upto 80 years of age with transverse fractures (AO/ASIF 34-C1) presenting to our center within 1 week of trauma and willing to provide consent for the study were included. |
|
| ExclusionCriteria |
| Details |
1.Patients with multiple fractures of the same limb
2.Patients who are not willing to participate in the study or unfit for surgery
3.Patients with floating knee
4.Patients with pathological fractures
5.Patients with open fractures
6.Patients with comminuted patella fractures
7.Patients with fractures where tension band wiring or use of 4 mm cannulated screws is not technically feasible were excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Radiological union, Knee Society score, Range of motion and post-operative complications |
2 weeks, 6 weeks, 12 weeks, 24 weeks follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Advantages and disadvantages of both methods.
Hardware failure and ease of implant removal.
|
2 weeks, 6 weeks, 12 weeks, 24 weeks follow up |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
24/06/2024 |
| 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="6"
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
|
This is a non-blinded prospective randomized study comprising two groups with closed transverse patella fractures. One group is to be treated with tension band wiring using 4 mm cannulated screws (CCS group) as against control group who are to be treated with tension band wiring using two Kirschner wires (K wire group). Outcomes to be measured are radiological union, knee society score, range of motion and postoperative complications and are to be compared between the two groups. |