| CTRI Number |
CTRI/2023/08/056490 [Registered on: 14/08/2023] Trial Registered Prospectively |
| Last Modified On: |
13/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
In this we will assess pre & post status of different Posterior Cruciate Ligament Injuries managed surgically |
|
Scientific Title of Study
|
Outcome Analysis of Posterior Cruciate Ligament Injuries |
| 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 Anmol Suneja |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Orthopaedics, Jawaharlal Nehru Medical College
Sawangi(Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
9996944461 |
| Fax |
|
| Email |
anmolsuneja12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Deshpande |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Orthopaedics, Jawaharlal Nehru Medical College
Sawangi(Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
9860452519 |
| Fax |
|
| Email |
svd1111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anmol Suneja |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Orthopaedics, Jawaharlal Nehru Medical College
Sawangi(Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
9996944461 |
| Fax |
|
| Email |
anmolsuneja12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural hospital, Datta Meghe Institute of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Department of Orthopaedics, Datta Meghe Institute of Higher Education and Research |
| 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 Anmol Suneja |
Acharya Vinoba Bhave Rural Hospital |
Department of Orthopaedics, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi(Meghe)
Wardha
MAHARASHTRA |
9996944461
anmolsuneja12@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: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Non randomised clinical trial |
According to the scoring system (Lysholm knee scoring and IKDC knee scoring) we will assess pre and post injury parameters of the patients |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Included in the study will be all skeletally matured patients of age 25 years and above, both male and female, with symptoms and traumatic PCL injuries planned for surgical management |
|
| ExclusionCriteria |
| Details |
Exclusion criteria will be patients with injuries to the PCL who will be managed conservatively, injuries to the PCL that have infectious foci, tumor conditions, osteoarthritic changes, and congenital and metabolic disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients managed surgically for posterior cruciate ligament injuries showed improvement in scoring & better results |
Patients will be assessed post operatively after 1 month 3 months 6 months & 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
12/09/2023 |
| 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 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
|
Introduction - Posterior cruciate ligament, a major stabiliser of the knee restrains the posterior translation of tibia over femur. Injury to the two bundles of this ligament is usually seen in a motor vehicle accident, followed by dashboard injury. Aim and Objective - Outcome Analysis of Posterior Cruciate Ligament Injuries. Methodology - Non- operative management post posterior cruciate ligament tears includes non-steroidal anti-inflammatory drugs and rehabilitation. Common surgical procedures include trans- tibial tunnel or tibial inlay technique of graft reconstruction, single bundle or double bundle reconstruction. Literature on outcomes of posterior cruciate ligament injuries managed with either of the methods is less, we therefore aim to conduct an interventional study to analyse the patient’s functional status and satisfaction post treatment. Outcome Measures - Lysholm Knee scoring scale and Knee society scoring system are used as outcome measures. The follow up scores are taken post six, twelve, fifteen and twenty four months of the treatment. |