| CTRI Number |
CTRI/2025/12/098435 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Different types of surgical fixaion of proximal tibia by plating |
|
Scientific Title of Study
|
A Comparative study on Functional and Radiological outcome of bicolumnar vs column specific fixation of Proximal tibia fracture ( Schatzker type 5 and type 6 ) |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DSidharthan |
| Designation |
Post Graduate |
| Affiliation |
SRM Medical College Hospital and Research centre. |
| Address |
G block , 2nd floor , department of orthopaedics , SRM Medical College Hospital and Research centre , kattankulathur campus.
Chennai
TAMIL NADU
603203
India |
| Phone |
9600553871 |
| Fax |
|
| Email |
sd5721@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.E.Dilip kumar Naidu |
| Designation |
Professor,Department of orthopaedics |
| Affiliation |
SRM Medical College Hospital and Research centre. |
| Address |
G block , 2nd floor , department of orthopaedics , SRM Medical College Hospital and Research centre , kattankulathur campus.
Chennai
TAMIL NADU
603203
India |
| Phone |
9884460536 |
| Fax |
|
| Email |
dilipkum@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DSidharthan |
| Designation |
Post Graduate |
| Affiliation |
SRM Medical College Hospital and Research centre. |
| Address |
G block , 2nd floor , department of orthopaedics , SRM Medical College Hospital and Research centre , kattankulathur campus.
Chennai
TAMIL NADU
603203
India |
| Phone |
9600553871 |
| Fax |
|
| Email |
sd5721@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical college hospital and research centre,kattankulathur campus,chengalpattu district,Tamil nadu - 603203,India. |
|
|
Primary Sponsor
|
| Name |
D.Sidharthan |
| Address |
No.43 , 7 th cross street , baliah garden , thilakar avenue , madipakkam , chennai - 600091 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| sidharthan |
SRM medical college hospital and research centre |
G block , 2nd floor , department of orthopedics.
Kancheepuram
TAMIL NADU |
9600553871
sd5721@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM medical college hospital and research centre instituitional ethics 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 |
| Comparator Agent |
open reduction internal fixation with bicolumnar plating |
Total Duration - 6 months |
| Intervention |
open reduction internal fixation with column specific plating for proximal tibia. |
Total Duration - 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All Skeletally mature patients (more than 18 years of age)
Closed tibial plateau fractures (schatzker type V and VI )planned for open reduction and internal fixation in single or two stage
Patient willingness for follow up
|
|
| ExclusionCriteria |
| Details |
Age less than 18
Paraplegia,quadriplegia and patient with terminal illness like leukemia etc
Peripheral Diabetic Neuropathy
Proximal Femoral Focal Deficiency
Osteogenesis Imperfecta
Hemimelia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Functional outcome:
Modified Rasmussen Clinical Scoring System
VAS pain scale
Radiological outcome:
Modified Rasmussen Radiologiccal Scoring System
CT-scan
X-Ray |
2 weeks , 6 weeks , 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| better functional outcomes after surgical intervention |
6 weeks , 3 months , 6 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
15/12/2025 |
| 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="0"
Months="6"
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
|
Tibial plateau fractures are significant intra-articular injuries, especially Schatzker type V and VI, often resulting from high-energy trauma. Evolving radiological classifications, such as Luo’s three-column approach using CT scans, have improved the understanding and management of these complex fractures. Emerging fixation methods include bicolumnar and column-specific plating, with each technique offering distinct biomechanical and clinical advantages
.Aim of Study The primary aim is to compare the functional and radiological outcomes in tibial plateau fractures (Schatzker type V and VI) managed with column-specific fixation versus bicolumnar fixation.
Study Design This research is designed as a prospective, randomized, comparative single-centre study. Adult patients with closed tibial plateau fractures (Schatzker type V and VI) requiring surgical fixation are included based on strict inclusion and exclusion criteria
Methodology Participants are randomly assigned to either bicolumnar or column-specific fixation groups. Functional outcomes are evaluated using the Modified Rasmussen Clinical Scoring System and VAS pain scale, while radiological outcomes are assessed via the Modified Rasmussen Radiological Scoring System, CT scan, and X-ray at set follow-up intervals. The planned sample size is 66 patients, with follow-up at 2 weeks, 6 weeks, 3 months, and 6 months post-operation. Standardized surgical approaches (posteromedial and anterolateral) are detailed, and ethical procedures including informed consent are strictly followed.
Expected Outcomes Column-specific fixation is hypothesized to yield superior functional and radiological outcomes compared to bicolumnar fixation in complex tibial plateau fractures. The study also anticipates providing comparative data on complication rates, early mobilization, pain, and time to return to normal activity.
Significance Findings from this study are expected to guide evidence-based selection between bicolumnar and column-specific fixation, leading to improved management strategies, reduced complications, and better patient outcomes for complex tibial plateau fractures
|