| CTRI Number |
CTRI/2020/04/024716 [Registered on: 17/04/2020] Trial Registered Prospectively |
| Last Modified On: |
01/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Key Hole Repair of Shoulder Cuff With Rehab Programm |
|
Scientific Title of Study
|
Study Of Functional Outcome Of Arthroscopic Rotator Cuff Repair With Focused Rehab Program |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr H Varrdhaman Dhariwal |
| Designation |
SR.Asst Professor |
| Affiliation |
Stanley Medical College |
| Address |
OPD no2,department of orthopaedics
old washermanpet,stanley medical college
Chennai
TAMIL NADU
600001
India |
| Phone |
9444045056 |
| Fax |
|
| Email |
varrdh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Varrdhaman Dhariwal |
| Designation |
SR.Asst Professor |
| Affiliation |
Stanley Medical College |
| Address |
OPD no2,department of orthopaedics
old washermanpet,stanley medical college
TAMIL NADU
600001
India |
| Phone |
9444045056 |
| Fax |
|
| Email |
varrdh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr H Varrdhaman Dhariwal |
| Designation |
SR.Asst Professor |
| Affiliation |
Stanley Medical College |
| Address |
OPD no2,department of orthopaedics
old washermanpet,stanley medical college
TAMIL NADU
600001
India |
| Phone |
9444045056 |
| Fax |
|
| Email |
varrdh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Stanley Medical College ,Old Washermanpet, Chennai-1 |
|
|
Primary Sponsor
|
| Name |
Stanley Medical College |
| Address |
Depat of Orthopaedics,Stanley Medical College |
| 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 |
| DR VARRDHAMAN DHARIWAL H |
Stanley Govt Hospital |
(Opd No2) Depatment of Orthopaedics,old washermanpet,chennai-1
Chennai
TAMIL NADU |
9444045056
varrdh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| STANLEY MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M751||Rotator cuff tear or rupture, notspecified as traumatic, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Rotator Cuff Repair |
|
| ExclusionCriteria |
| Details |
Open Surgery,Beighton Score>6,Severe Osteoporosis & Malacia,local sepsis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Function score,Pre Operatively,Post Operatively ,4WEEKS, 8WKS,12WKS,20WKS,6M,1Y ,1.5,2Y,2.5Y,3Y |
8WKS,12WKS,20WKS,6M,1Y ,1.5,2Y,2.5Y,3Y |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional score,Pre Operatively ,Post Operatively |
4WEEKS, 8WKS,12WKS,20WKS,6M,1Y ,1.5Y,2Y,2.5Y,3Y |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
21/04/2020 |
| 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="5"
Months="11"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Arthroscopic functional score of Rotator cuff tear cases done in our population especially with a good rehab programme is important as the technique evolves especially with the transosseous technique how valuabe is the outcome (instumentsTechnique made by Dr.Senthilvelan.R MBBS,MRCS(UK), FRCS(ORTHO UK),FEBOT(France).
|