| CTRI Number |
CTRI/2021/08/036086 [Registered on: 31/08/2021] Trial Registered Prospectively |
| Last Modified On: |
30/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
OUTCOMES OF TWO APPROACHES OF TIBIAL NAILING A RANDOMIZED CONTROLLED TRIAL
|
|
Scientific Title of Study
|
ASSESSMENT OF FUNCTIONAL AND RADIOLOGICAL OUTCOMES OF SUPRAPATELLAR AND INFRAPATELLAR APPROACHES OF TIBIAL NAILING IN PATIENTS WITH TIBIA SHAFT FRACTURE: A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
TIBNAIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MANTU JAIN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
ROOM NUMBER 15
DEPARTMENT OF ORTHOPEDICS
AIIMS BHUBANESWAR
Khordha
ORISSA
751019
India |
| Phone |
9090471731 |
| Fax |
|
| Email |
montu_jn@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MANTU JAIN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
ROOM NUMBER 15
DEPARTMENT OF ORTHOPEDICS
AIIMS BHUBANESWAR
ORISSA
751019
India |
| Phone |
9090471731 |
| Fax |
|
| Email |
montu_jn@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
MANTU JAIN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
ROOM NUMBER 15
DEPARTMENT OF ORTHOPEDICS
AIIMS BHUBANESWAR
ORISSA
751019
India |
| Phone |
9090471731 |
| Fax |
|
| Email |
montu_jn@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS BHUABNESWAR |
| Address |
SIJUA
DUMDUMA |
| 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 |
| Soyam S panda |
AIIMS Bhubaneswar |
room 15
orthopedic OPD
AIIMS Bhubaneswar
Sijua
Dumduma
Khordha
ORISSA |
9090471731
sspanda.dr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S822||Fracture of shaft of tibia, (2) ICD-10 Condition: S822||Fracture of shaft of tibia, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Infrapatellar approach |
Tibial shaft fracture will be treated by nailing using infrapatellar approach and followed-up for total of one year |
| Comparator Agent |
Suprapatellar approach |
Tibial shaft fracture will be treated by nailing using Suprapatellar approach and followed-up for total of one year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Isolated tibia shaft fractures
2. Skeletally matured, age >18 years
|
|
| ExclusionCriteria |
| Details |
1 multiple fractures of Ipsilateral limb
2.Refracture of tibia
3.Intra-articular tibia fractures
4.Arthritic knee
5.Open tibia shaft fractures
6.Neuromuscular diseases of lower limb
7.Pathological fractures
8.Any other complications
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To access the functional outcome of tibia shaft fracture comparing the SPA and IPA in tibial intramedullary nailing using the Lysholm knee score. |
3 momnths, 6 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To access the radiological outcome of tibia shaft fracture in terms of fracture reduction among the groups.
|
12 months |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Tibia shaft fractures are due to the high-end energy
trauma and more common long bone to get fractured, approximately 2% of all
fractures in adult. Presently reamed Intramedullary nailing of the tibia with
additional interlocking screws for the axial and rotational stability is preferred
for unstable tibia shaft fracture.
Traditionally,
an infrapatellar port between the articular surface of the knee and tibial
tubercle, lateral to tibial tubercle is practiced. This
approach requires cutting or splitting of the patellar tendon and sometimes
there is transection of the
infrapatellar nerve, a branch of the saphenous nerve during the procedure. This
iatrogenic damage leads to anterior knee pain in few patients (10 to 80%). Also,
due to the quadriceps extensor complex pull, the conical shape of tibial
metaphysis, and hyperflexion positioning intraoperatively, any angulated entry to the tibia during nailing leads to
malalignment and difficulty to maintain reduction for imaging.
To overcome
these challenges, a novel entry port in a semi-extended knee
at a flexion of 15-20 degrees was proposed. This new Suprapatellar approach of tibial Intramedullary
Interlocking Nailing (IMILN) allows easy reduction, lesser fluoroscopy time,
decreased malalignment, and reduces the anterior knee pain with equivalent
functional outcome.
There are a few studies that
show the superiority of Suprapatellar Approach (SPA) vs Infrapatellar Approach (IPA).
These are majorly western literature and extensive research on the Indian
population is lacking. Hence a study to further declutter in the Indian setup
is required. |