| CTRI Number |
CTRI/2023/04/051982 [Registered on: 26/04/2023] Trial Registered Prospectively |
| Last Modified On: |
19/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Observational |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess success after knee surgery |
|
Scientific Title of Study
|
A Single Centre, Retrospective, Observational Study to Assess the Safety and Functional Outcomes after Arthroscopic Meniscal repair using Surestitch All inside meniscal repair implant |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SH-Arthroscopy-Implant-2022, 5 December 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dhammapal Sahebrao Bhamare |
| Designation |
Head of Sports Medicine Department and orthopedic consultant |
| Affiliation |
Sainath Hospital |
| Address |
Sainath Hospital, Sant Nagar, Moshi Pradhikaran, Pune - Nashik Highway, Moshi
Pune
MAHARASHTRA
412105
India |
| Phone |
7507899338 |
| Fax |
|
| Email |
drbhamareds@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhammapal Sahebrao Bhamare |
| Designation |
Head of Sports Medicine Department and orthopedic consultant |
| Affiliation |
Sainath Hospital |
| Address |
Sainath Hospital, Sant Nagar, Moshi Pradhikaran, Pune - Nashik Highway, Moshi
Pune
MAHARASHTRA
412105
India |
| Phone |
7507899338 |
| Fax |
|
| Email |
drbhamareds@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhammapal Sahebrao Bhamare |
| Designation |
Head of Sports Medicine Department and orthopedic consultant |
| Affiliation |
Sainath Hospital |
| Address |
Sainath Hospital, Sant Nagar, Moshi Pradhikaran, Pune - Nashik Highway, Moshi
Pune
MAHARASHTRA
412105
India |
| Phone |
7507899338 |
| Fax |
|
| Email |
drbhamareds@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Healthium Medtech Limited |
|
|
Primary Sponsor
|
| Name |
Dr Dhammapal Sahebrao Bhamare |
| Address |
Sainath Hospital, Sant Nagar, Moshi Pradhikaran, Pune - Nashik Highway, Moshi, Pune -412105, Maharashtra, India |
| Type of Sponsor |
Other [] |
|
|
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 Dhammapal Sahebrao Bhamare |
Sainath Hospital |
Room No 1, Orthopedics OPD, Sant Nagar, Moshi Pradhikaran, Pune - Nashik Highway, Moshi,
Pune
MAHARASHTRA |
7507899338
drbhamareds@yahoo.co.in |
|
|
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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged more than 18 years who has undergone meniscal repair surgery with Surestitch All-inside meniscal repair implant, between January 2019 to July 2022
2. Patients willing to provide verbal consent for the study during the telephonic follow-up visit |
|
| ExclusionCriteria |
| Details |
1.Patients who have suffered from Traumatic injury to the same knee after meniscus repair surgery
2. Patients who cannot be contacted after 3 attempts |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the postoperative subjective knee function after meniscal repair using Surestitch implants |
One followup after EC approval 6 months to 4.5 years after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To review the safety of Surestitch implants in meniscal repair by evaluating adverse events after surgery.
2. To compare the activity level in patients before and after meniscal repair.
3. To evaluate the knee pain after meniscal repair.
4. To evaluate the knee specific symptoms after meniscal repair.
|
One followup after EC approval 6 months to 4.5 years after surgery |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/05/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a single-centre, retrospective, observational study to assess the safety and functional outcomes after arthroscopic meniscal repair using surestitch all inside meniscal repair implant. All patients who had undergone meniscus repair using Surestitch all inside meniscal repair implant between January 2019 to September 2022 will be included in the study. |