| CTRI Number |
CTRI/2024/04/066181 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess success of healing after knee injury repair |
|
Scientific Title of Study
|
Assessment of meniscal healing after all-inside meniscus repair |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sidharth Sasikumar |
| Designation |
MS Orthopedics resident |
| Affiliation |
Amrita institute of medical science |
| Address |
Room no 7, 7th floor, Department of Orthopedics, Ponekkara, Edappally, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9686084610 |
| Fax |
|
| Email |
sidharthpallath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jai Thilak |
| Designation |
HOD department of Orthopedics |
| Affiliation |
Amrita institute of medical science |
| Address |
Room no 7, 7th floor, Department of Orthopedics, Ponekkara, Edappally, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9446543346 |
| Fax |
|
| Email |
jaithilak@aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jai Thilak |
| Designation |
HOD department of Orthopedics |
| Affiliation |
Amrita institute of medical science |
| Address |
Room no 7, 7th floor, Department of Orthopedics, Ponekkara, Edappally, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9446543346 |
| Fax |
|
| Email |
jaithilak@aims.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Amrita institute of medical science, Ponekkara road, Edappally, Kochi, Kerala- 682041 |
|
|
Primary Sponsor
|
| Name |
Amrita institute of medical science |
| Address |
Ponekkara road, Edappally, Kochi, Kerala- 682041 |
| 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 Sidharth Sasikumar |
Amrita institute of medical science |
Room no 7, 7th floor, Department of Orthopedics, Ponekkara, Edappally, Kochi
Ernakulam
KERALA |
9686084610
sidharthpallath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of Amrita School of Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M232||Derangement of meniscus due to oldtear or injury, (2) ICD-10 Condition: M238||Other internal derangements of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Month(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients who have undergone all-inside arthroscopic meniscus repair with or without ACL reconstruction done at Amrita Institute of medical science |
|
| ExclusionCriteria |
| Details |
- Patients not willing for necessary imaging
- Patients with post-operative joint infection or trauma |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Meniscal healing post all-inside meniscus repair |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Peri-meniscal cyst incidence after meniscus repair
2. PRP in meniscus healing
3. Meniscal healing with isolated meniscus and concomitant ACL injury |
18 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/05/2024 |
| 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
|
Patients who underwent all-inside meniscus repair are selected. Patient clinically assessed with scoring system KOOS score, Marx score, SF-36 physical component score before and after surgery. MRI done for patients beyond 6 months Crues grading done to classify tears pre-operatively and Henning’s criteria done for assessing healing. Proportion of patients with no healing, partial healing and complete healing calculated. Inferences drawn on proportion of healing (Primary objective) and secondary objectives |