| CTRI Number |
CTRI/2020/05/025377 [Registered on: 27/05/2020] Trial Registered Prospectively |
| Last Modified On: |
16/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
EVALUATION OF ARTHROSCOPIC P0STERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING PERONEUS LONGUS GRAFT BY NEW SURGICAL TECHNIQUE. |
|
Scientific Title of Study
|
CLINICORADIOLOGICAL EVALUATION OF ARTHROSCOPIC PCL RECONSTRUCTION USING AUTOGENOUS PERONEUS LONGUS GRAFT BY ALL INSIDE TECHNIQUE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kunal Gautam |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department Of Orthopaedic Surgery, Maulana Azad Medical College, New Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
7011813472 |
| Fax |
|
| Email |
kunalgautam.pankaj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Kumar |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department Of Orthopaedic Surgery, Maulana Azad Medical College, New Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
9968604321 |
| Fax |
|
| Email |
drvk706@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod Kumar |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department Of Orthopaedic Surgery, Maulana Azad Medical College, New Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
9968604321 |
| Fax |
|
| Email |
drvk706@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Department Of Orthopaedic Surgery, Maulana Azad Medical College, New Delhi 110002 |
| 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 |
| Kunal Gautam |
LOK NAYAK HOSPITAL |
Department Of Orthopaedic Surgery,Maulana Azad Medical College, New Delhi 110002
New Delhi
DELHI |
7011813472
kunalgautam.pankaj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M236||Other spontaneous disruption of ligament(s) of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arthroscopic PCL Reconstruction Using Autogenous Peroneus Longus Graft By All Inside Technique |
Reconstruction Using Autogenous Peroneus Longus Graft By All Inside Technique |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinicoradiolologically diagnosed grade 2 or more posterior instability due to PCL tear.
2. Age between 18 and 60 yrs. |
|
| ExclusionCriteria |
| Details |
1. Patients having pre-existing degenerative changes in the knee.
2. Infections, inflammatory or neoplastic condition in periarticular area.
3. Patients having any acute PCL bony avulsion injuries requiring fixation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. IKDC score and clinical evaluation.
2. American Orthopaedic Foot Ankle Society Score.
3. Foot Ankle Disability Index.
4. Cincinnati Rating System.
|
1. IKDC score and Cincinnati Rating System at preoperative,2 weeks postoperative,6 weeks postoperative,3 months and 6 months.
2. American Orthopaedic Foot Ankle Society Score and Foot Ankle Disability Index at 2 weeks postoperative,6 weeks postoperative,3 months and 6 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. X- Rays
2. CT
3. MRI
|
1.X-Rays to be done in immediate post op,at 2 weeks, 6 weeks, 3 months and 6 months.
2. CT evaluation at 6 months.
3. MRI evaluation at 6 months |
|
|
Target Sample Size
|
Total Sample Size="7"
Sample Size from India="7"
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
|
N/A |
|
Date of First Enrollment (India)
|
29/05/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective interventional study evaluating clinicoradiological outcomes of arthroscopic PCL reconstruction using autogenous peroneus longus graft using all inside technique and evaluating the graft site morbidity incase of peroneus longus autograft |