| CTRI Number |
CTRI/2024/10/075422 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Meniscal root repair with implant |
|
Scientific Title of Study
|
A Single Centre Study to Assess the Safety and Functional Outcomes after Arthroscopic Meniscal Repair using T Button R® Meniscus Root Repair Implant |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Arthro-Knee-001, Version 1.0, Date 01/07/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neeraj Adkar |
| Designation |
Medical Director |
| Affiliation |
Saishree Hospital |
| Address |
Department of Orthopaedics
Saishree Hospital
Survey Number 157 Plot Number 26 DP Road
Landmark Near DAV Public School and Opposite to Subway
Pune
MAHARASHTRA
411007
India |
| Phone |
09822051881 |
| Fax |
|
| Email |
knee.expert@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeraj Adkar |
| Designation |
Medical Director |
| Affiliation |
Saishree Hospital |
| Address |
Department of Orthopaedics
Saishree Hospital
Survey Number 157 Plot Number 26 DP Road
Landmark Near DAV Public School and Opposite to Subway
Pune
MAHARASHTRA
411007
India |
| Phone |
09822051881 |
| Fax |
|
| Email |
knee.expert@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeraj Adkar |
| Designation |
Medical Director |
| Affiliation |
Saishree Hospital |
| Address |
Department of Orthopaedics
Saishree Hospital
Survey Number 157 Plot Number 26 DP Road
Landmark Near DAV Public School and Opposite to Subway
Pune
MAHARASHTRA
411007
India |
| Phone |
09822051881 |
| Fax |
|
| Email |
knee.expert@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saishree Hospital
Survey Number 157, Plot Number 26, DP Road,
Landmark: Near DAV Public School & Opposite to Subway,
Pune, Maharashtra 411007
|
|
|
Primary Sponsor
|
| Name |
Dr Neeraj Adkar |
| Address |
Saishree Hospital
Survey Number 157 Plot Number 26 DP Road
Landmark Near DAV Public School and Opposite to Subway |
| 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 Neeraj Adkar |
Saishree Hospital |
Department of Orthopaedics,
Saishree Hospital
Survey Number 157 Plot Number 26 DP Road
Landmark Near DAV Public School & Opposite to Subway
Pune Maharashtra 411007
Pune
MAHARASHTRA |
9822051881
knee.expert@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Not Applicable |
| Intervention |
T Button R® (Meniscus Root
Repair Implant) |
T Button R Meniscus Root Repair Implant is a permanently implantable Polyether Ether Ketone (PEEK) fixation device used for fixation of meniscus root tear. Once applied it will not be removed from the body and stays as a permanent implant. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Male/ female participants between 18 -70 years
2.Participants with meniscal root tear which requires surgical repair
3.Participants who are willing to provide written Informed Consent and comply with study procedures
|
|
| ExclusionCriteria |
| Details |
1.Participants with BMI ≥35 kg/m2
2.Participants who had undergone previous surgery in the same or contralateral knee
3.Participants with a history of deep vein thrombosis (DVT)
4.Participants with any condition which makes the subject unsuitable for study participation which as per the investigator would jeopardize the outcome of the trial or participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this study
5.Pregnant and lactating female at the time of screening
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess functional outcomes of Knee post- meniscal root repair |
Screening/ Baseline, month 1.5, month 6 and month 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the clinical symptoms and activity
level in the eligible subjects who will undergo
meniscal root repair. |
Change in the following will be assessed from
Screening/ Baseline (pre-surgery) to 12 months
post-operatively using: -
- Knee specific symptoms as measured by
Lysholm knee score [Time frame: Screening/
Baseline, month 1.5, month 6 and month 12]
- Tegner activity scale score [Time frame:
Screening/ Baseline, month 1.5, month 6 and
month 12]
- SANE (Single Assessment Numeric Evaluation)
[Time frame: Screening/ Baseline, month 1.5,
month 6 and month 12] |
To assess the failure rate of meniscal root repair
using T Button R® Meniscus Root Repair
Implant in the eligible subjects |
Failure will be assessed on the basis of
symptoms requiring revision using Meniscus
Root Repair surgery. [Time frame: All visits after
surgery including surgery day] |
To assess change in quality of life in patients
who will undergo meniscal root repair using T
Button R® Meniscus Root Repair Implant |
Quality of life post meniscal root repair surgery
via Modified Knee Injury and Osteoarthritis
Outcome Score (KOOS) [Time frame: Screening/
Baseline, month 12] |
To assess recovery period in patients who will
undergo meniscal root repair using T Button R®
Meniscus Root Repair Implant |
Time to recovery as measured by mobilization
with support of braces/crutches, and mobilization
without support of braces/crutches [Time frame:
Day 15, month 1.5, month 6 and month 12] |
To assess the duration of surgery with T Button
R® Meniscus Root Repair Implant |
Duration of surgery in minutes [Definition: The
time interval from skin incision to closure in
minutes will be defined as duration of surgery] |
To assess the overall intraoperative handling of
T Button R® Meniscus Root Repair Implant |
Overall intraoperative handling with the study
product (score based on the ‘Intraoperative
assessment of the device by the investigator:
Overall ergonomics, Overall quality of implant,
Fixation strength, Maneuverability and Ease of
use) at the time of surgery |
To assess the safety of the T Button R®
Meniscus Root Repair Implant |
Intra- and post-operative complications: adverse
device effects (ADEs) and serious adverse
events (SAEs) [Time frame: All visits after
surgery including surgery day] |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This is a single centre prospective study to assess the safety and functional outcomes after arthroscopic meniscal root repair using meniscus root repair implant.
T Button R® Meniscus Root Repair Implant is intended for soft tissue fixation to the bone. It is indicated for surgeries which require soft tissue fixation to Bone specifically for Meniscus root repair. In the current study we plan to assess the safety and functional Outcomes after Arthroscopic Meniscal root repair using T Button R® Meniscus Root Repair Implant via change in IKDC, Lysholm knee score, Tegner activity scale scores, SANE and modified KOOS scale scores. Duration of surgery, failure rate of meniscal root repair and time to recovery will also be done as a part of efficacy assessment. Clinical data collected through this study will be of great benefit to the research field and potentially will be beneficial to society. |