| CTRI Number |
CTRI/2025/03/082019 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing different types of meniscal root repairs |
|
Scientific Title of Study
|
Comparing Arthroscopic Medial Meniscus Root Repair With and Without Centralization - A Randomized Controlled Study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swaroop M Jacob |
| Designation |
Junior resident , M.S orthopaedics |
| Affiliation |
SRM UNIVERSITY |
| Address |
Department of orthopaedics, srm medical college and research institute, srm university
Chennai
TAMIL NADU
603203
India |
| Phone |
7795661921 |
| Fax |
|
| Email |
swaroopmjacob@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajavel K |
| Designation |
Professor and unit chief , department of orthopaedics |
| Affiliation |
SRM medical College hospital and research centre , srm university |
| Address |
Department of orthopaedics, srm medical college and research institute,
Chennai
TAMIL NADU
603203
India |
| Phone |
7395848250 |
| Fax |
|
| Email |
rajavelk@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Swaroop M Jacob |
| Designation |
Junior resident , department of orthopaedics |
| Affiliation |
SRM medical College hospital and research centre , srm university |
| Address |
Department of orthopaedics, srm medical college and research institute
Chennai
TAMIL NADU
603203
India |
| Phone |
7795661921 |
| Fax |
|
| Email |
swaroopmjacob@gmail.com |
|
|
Source of Monetary or Material Support
|
| Srm medical college and research institute, srm university, katankulathur, chengalpet, tamil nadu, india, 603203 |
|
|
Primary Sponsor
|
| Name |
Swaroop M jacob |
| Address |
#3188 21D main vijaynagar 2nd stage mysore 570017 |
| 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 |
| Dr Swaroop M jacob |
Srm medical college hospital and research institute |
Office, Department of orthopaedics,
2nd floor, srm medical college building, katankulathur, chengalpet
Chennai
TAMIL NADU |
7795661921
swaroopmjacob@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Srm medical college institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: S832||Tear of meniscus, current injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arthroscopic Medial meniscus root repair with centralization |
suture anchors made from biocompatible materials like polylactic acid (PLA) or absorbable polymers, along with specialized sutures (often FiberWire) passed through the meniscus and anchored into the tibial bone to reposition and stabilize the torn meniscus tissue |
| Comparator Agent |
Primary Arthroscopic Medial meniscus root repair only |
The torn Medial meniscus is repaired arthroscopically using all inside or inside out techniques with the help of sutures |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with complete degenerative posterior root tear(LaPrade type2,3,4,5) of the medial meniscus based on magnetic res imaging (MRI) findings |
|
| ExclusionCriteria |
| Details |
BMI greater than 35,Comorbid conditions like uncontrolled diabetes, thyroid disorders Inflammatory arthritis, Previous knee surgeries |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lysholm knee scoring scale,Objective and subjective IKDC criteria, VAS pain score , improvements |
3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced progression of severity of osteoarthritis of knee determined by standing X rays of knee |
1 year , 3 years |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
10/03/2025 |
| 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="1"
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
|
Over the years, studies regarding meniscus and the importance of meniscal tears have evolved Meniscus root tears were thought to be an incidental finding in an MRI scan, and it was not addressed Recent literature has thrown light on the importance of root repair and thus surgeons worldwide have begun repa meniscus root The standard arthroscopic medial meniscus root repair technique fails to address meniscal extrusion, a common Meniscal centralisation is advised additionaly to repair to address this issue Unfortunately, the available literature regarding this is scarce. Thus, we propose to comapre medial meniscal root repair with and without centralisation and evaluate the functional outcome |