| CTRI Number |
CTRI/2024/11/077216 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of upper tibia fracture using Nail. |
|
Scientific Title of Study
|
Outcome of Suprapatellar Nailing in Extra-articular proximal third tibial 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 |
Dr Krishna D Sambare |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept of Orthopedic Surgery
Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha MAHARASHTRA 442107 India |
| Phone |
9284225941 |
| Fax |
|
| Email |
krishnasambare786@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ratnakar Ambade |
| Designation |
Professor and head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept of Orthopedic Surgery
Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha MAHARASHTRA 442107 India |
| Phone |
9823033511 |
| Fax |
|
| Email |
drambade@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ratnakar Ambade |
| Designation |
Professor and head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept of Orthopedic Surgery
Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
MAHARASHTRA 442107 India |
| Phone |
9823033511 |
| Fax |
|
| Email |
drambade@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
Datta Meghe Institute of Higher Education and Research Sawangi Wardha India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Wardha India 442001 |
| Type of Sponsor |
Private 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 Krishna D Sambare |
Shalinitai Meghe Superspeciality Center |
Second floor Dept. of Orthopedic surgery, SMSC building Sawangi Meghe,442001 Wardha MAHARASHTRA |
9284225941
krishnasambare786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Suprapatellar Nailing in Extra-articular proximal third Tibial fractures. |
Cases of Extra-articular proximal third Tibial fractures will be treated with suprapatellar nailing.
assessment will be done post operatively for functional and radiological outcome and follow up at 3, 6, 9 month will be done. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years.
Extra-articular proximal third tibial fracture Orthopedic Trauma Association type 41 A2 A3
Closed and Gustilo Anderson open type 1, II, IIIA |
|
| ExclusionCriteria |
| Details |
Fractures involving the articular surface of tibia, Pathological Fractures, infective pathologies compound Gustilo and Anderson open type IIIB and C fractures to be excluded.
Extra-articular Proximal third tibial fractures associated with other lower limb ipsilateral or contralateral fractures to be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Radiological and functional outcome of suprapatellar nailing in extra-articular proximal third tibial fracture will be evaluated. |
Assessment will be done at the end of 1 month, 3 month, 6 month, and 9 month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
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)
|
01/01/2025 |
| 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 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
|
Fracture of tibia are one of the most common long bone fracture in general population now a days due to increasing trend in the high velocity and high energy trauma mechanisms associated with road traffic accidents and other traumatic injuries. They constitute about 17% of all lower limb fractures. Extraarticular proximal-third fractures of Tibia account for 5% to 11% of all tibial shaft fractures Proximal tibia fracture are frequently associated with high energy trauma mechanisms. For diaphyseal factures of tibia intramedullary nailing is considered as the gold standard. standard tibia nailing are done via infra and parapatellar approaches , suprapatellar tibia nailing is the recent advance in the surgical technique for treatment of tibia fracture, as it have better outcome according to previously conducted studies. For tibia nailing can be considered superior to other conventional approaches in terms of lesser post op knee pain, load sharing, preservation of Extraosseous blood supply, very minimal soft tissue dissection thereby reducing the risk of postoperative complications. shorter fluoroscopy time , less vas score, better sagittal plane alignment , lower incidence of angular malalignment , better functional recovery, and improved fracture reduction. with no increased risk of post operative complication. This study aims to assess radiological and functional outcome of suprapatellar nailing in Extra articular proximal third tibial fracture. |