| CTRI Number |
CTRI/2024/10/075522 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two methods of rod fixation for treating leg bone fractures |
|
Scientific Title of Study
|
Suprapatellar versus Infrapatellar Approach for Intramedullary Nailing of Tibial Diaphyseal Fractures: A Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arindam Kumar Bhowmik |
| Designation |
Resident Doctor Orthopaedic Surgery |
| Affiliation |
Department of Orthopaedic Surgery, Jawaharlal Nehru Medical College and Hospital |
| Address |
Department of Orthopaedic Surgery, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8617067011 |
| Fax |
|
| Email |
bhowmik.arindam1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Latif Zafar Jilani |
| Designation |
Professor |
| Affiliation |
Department of Orthopaedic Surgery, Jawaharlal Nehru Medical College and Hospital |
| Address |
Department of Orthopaedic Surgery, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8979570450 |
| Fax |
|
| Email |
lzjilani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Latif Zafar Jilani |
| Designation |
Professor |
| Affiliation |
Department of Orthopaedic Surgery, Jawaharlal Nehru Medical College and Hospital |
| Address |
Department of Orthopaedic Surgery, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8979570450 |
| Fax |
|
| Email |
lzjilani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh,202002 |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not Applicable ] |
|
|
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 Arindam Kumar Bhowmik |
Jawaharlal Nehru Medical College and Hospital |
Department of Orthopedic Surgery
Aligarh
UTTAR PRADESH |
08617067011
bhowmik.arindam1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE REGD. Jawaharlal Nehru Medical College and hospital Faculty of Medicine Aligarh Muslim University Aligarh UP 202002 |
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 |
Infrapatellar Approach in tibia intramedullary nailing |
In this approach of intramedullary nailing of tibial diaphyseal fracture is done by infrapatellar approach that refers to giving incision from inferior pole of patella to tibial tuberosity. |
| Comparator Agent |
NA |
NA |
| Intervention |
Suprapatellar Approach in tibia intramedullary nailing |
In this approach of intramedullary nailing of tibial diaphyseal fracture is done by suprapatellar approach that refers to giving incision above superior pole patella. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Skeletally mature patients
Tibial Shaft fractures
Closed / Gustilo & Anderson Open Type I & II |
|
| ExclusionCriteria |
| Details |
Polytrauma
Intraarticular extension of fracture
Pathological fracture
Patellar fracture
Open type III fracture
Previous tibial surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the results of intramedullary nailing of tibial diaphyseal fractures by suprapatellar and infrapatellar approaches in terms of Anterior Knee Pain |
6 weeks,3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the results of intramedullary nailing of tibial diaphyseal fractures by suprapatellar and infrapatellar approaches in terms of Fracture union |
6 weeks, 3 months, 6 months |
| To compare the results of intramedullary nailing of tibial diaphyseal fractures by suprapatellar and infrapatellar approaches in terms of Radiographic Alignment |
Post operative, 6 weeks, 3 months, 6 months |
| To compare the results of intramedullary nailing of tibial diaphyseal fractures by suprapatellar and infrapatellar approaches in terms of Operative Time |
During Surgery |
| To compare the functional outcomes of the two fixation techniques according to Lysholm Knee Score |
6 weeks, 3 months, 6 months |
| To assess complications among two groups |
Post operative,2 weeks, 6 week , 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
28/10/2024 |
| 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="0"
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
|
Several studies including recent meta-analysis demonstrated that suprapatellar approach may be superior to the infrapatellar approach in many aspects like easier reduction, decreased fluoroscopy time, less anterior knee pain. This study is done to compare the results of intramedullary nailing of tibial diaphyseal fractures by suprapatellar and infrapatellar approaches in terms of Operative Time, Radiographic Alignment, anterior knee pain, fracture union, functional outcomes and complications. |