| CTRI Number |
CTRI/2024/11/076774 [Registered on: 13/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two surgical approaches to lower leg fractures |
|
Scientific Title of Study
|
outcome analysis of comparison of transpatellar and medial parapatellar approach for intramedullary nailing in diaphyseal tibia fractures |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kautilya |
| Designation |
Junior Resident |
| Affiliation |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
| Address |
Dr RPGMC Tanda kangra ; dept of orthopedics
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8091795505 |
| Fax |
|
| Email |
bear.incorporative96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vipan Kumar |
| Designation |
Associate professor dept of Orthopaedics |
| Affiliation |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
| Address |
Dept of Orthopaedics room no 302
Dr RPGMC Tanda
HIMACHAL PRADESH
176001
India |
| Phone |
7018752724 |
| Fax |
|
| Email |
drvipanortho@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kautilya |
| Designation |
Junior Resident |
| Affiliation |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
| Address |
Dept of Orthopaedics, Dr RPGMC, Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8091795505 |
| Fax |
|
| Email |
bear.incorporative96@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad GovtMedical College Tanda |
| Address |
Dr RPGMC, Tanda, Kangra, HP, 176001 |
| 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 Kautilya |
Dr RPGMC Tanda |
Department of Orthopaedics / OPD 1
Kangra
HIMACHAL PRADESH |
8091795505
bear.incorporative96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Rajendra Prasad Government Medical College (Dr. RPGMC) Kangra at Tanda, Himachal Pradesh, India – 176 001 Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S822||Fracture of shaft of tibia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Medial parapatellar approach |
Patients with tibial fractures will be operated with this approach in which entry point for tibial nail insertion will be made just medial to patellar tendon thereby preserving patellar tendon unlike comparator approach . Subsequent steps for nail insertion are same
This is the second approach which will be subjected to patients |
| Comparator Agent |
Transpatellar approach |
Patients with tibial fractures will be operated with this approach in which patellar tendon will be split in order to make entry point for tibial nail insertion.
Then routine steps of tibial nailing will be followed subsequently
This is one type of surgical approach which will be subjected to trial patients |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients with open and closed tibial shaft fracture.
patients who give consent. |
|
| ExclusionCriteria |
| Details |
patients who are refusing to give consent.
any pathological fracture. Patients with diabetes, malnutrition, previous fracture of the same leg. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing anterior knee pain in two surgical approaches using VAS score |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing knee & ankle Range of motion postoperatively in two surgical approaches |
1 year |
|
|
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)
|
20/11/2024 |
| 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="1"
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
|
This study aims at comparing two Surgical approaches for Intramedullary Tibial Nailing in Postoperative period regarding certain parameters : 1) Anterior knee pain at 2,4 and 12 weeks postoperatively . 2.)Knee and ankle Range of Motion at 2,4 and 12 weeks postoperatively . 3.) Degree of Pain using VAS Scoring. 4.) Radiological union at 2,4 and 12 weeks |