| CTRI Number |
CTRI/2024/12/077871 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Recovery Outcomes: Arthroscopic vs. Mini Open Rotator Cuff Repair in a Randomized Trial |
|
Scientific Title of Study
|
Functional outcome of arthroscopic vs mini open rotator cuff repair: single blinded randomized control trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Rupam Baruah |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Science, Gorakhpur, Department of Orthopedics |
| Address |
All India Institute Of Medical Science, Gorakhpur, Department of Orthopaedics
Kunraghat, Gorakhpur, Uttar Pradesh 273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8724844495 |
| Fax |
|
| Email |
baruahrupam097@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir Shyam Kushwaha |
| Designation |
Associate professor, Department of Orthopedics, AIIMS, Gorakhpur |
| Affiliation |
All India Institute Of Medical Sciences, Gorakhpur |
| Address |
All India Institute Of Medical Sciences, Gorakhpur, Uttar Pradesh
273008
Department of orthopedics
Room no 10
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9415875238 |
| Fax |
|
| Email |
sudhirshyamkushwaha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudhir Shyam Kushwaha |
| Designation |
Associate professor, Department of Orthopedics, AIIMS, Gorakhpur |
| Affiliation |
All India Institute Of Medical Science, Gorakhpur, Uttar Pradesh, |
| Address |
All India Institute Of Medical Sciences, Gorakhpur, Uttar Pradesh, 273008
Department of orthopedics
Room no 10
All India Institute Of Medical Sciences, Gorakhpur, Uttar Pradesh
273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9415875238 |
| Fax |
|
| Email |
sudhirshyamkushwaha@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, Gorakhpur, Uttar Pradesh, India
Pin : 273008
|
|
|
Primary Sponsor
|
| Name |
Dr Rupam Baruah |
| Address |
All India Institute Of Medical Sciences, Gorakhpur, Uttar Pradesh, India
273008
|
| 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 Rupam Baruah |
All India Institute Of Medical Sciences, Gorakhpur |
Department of Orthopedics
Room No 10
Gorakhpur
UTTAR PRADESH |
8724844495
baruahrupam097@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human 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
|
| Type |
Name |
Details |
| Intervention |
rotator cuff repair by arthroscopic technique |
arthroscopic rotator cuff repair
Frequency:
1)Post-operative period during hospital stay
2)At 2 weeks when sutures will be removed
3)At 3 months
4)At 6 months
Duration: 18 Month |
| Comparator Agent |
rotator cuff repair by mini open technique |
rotator cuff repair by mini open technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group: 18 – 60 years of either gender with rotator cuff injury
2) Rotator cuff injury diagnosed clinically or confirmed by MRI
3) No previous history of injury or surgery in the effected shoulder
|
|
| ExclusionCriteria |
| Details |
1) Contraindication for Rotator cuff surgery such as active infection and fracture involving joint
2) Patients with local skin infection
3) Sign of glenohumeral instability or restricted glenohumeral movement
4) Inability or unwillingness to comply with study protocol follow up
5) Patient with Diabetes mellitus
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study would help us to evaluate and compare both techniques of Rotator cuff sugery with respect to their functional outcomes and related complications. The study would help us to determine which technique to be used according to individual patient |
1) Post-operative period during hospital stay
2) At 2 weeks when sutures will be removed
3) At 3 months
4 ) At 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of cuff integration between the two techniques after 6 month post operatively using MRI |
6 month postoperatively |
|
|
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)
|
01/01/2025 |
| 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="6"
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
|
This thesis which is being conducted in ALL INDIA INSTITUTE OF MEDICAL SCIENCE,GORAKHPUR investigates the functional outcomes of two surgical techniques for rotator cuff repair: arthroscopic and mini open methods. By conducting a Single blinded randomized control trial, the study Aims to compare the effectiveness of these approaches in terms of patient recovery, pain levels, and overall shoulder fuctions. The finding will provide valuable insights into which technique offers better long term outcomes , helping to guide clinical decision making and improve patient care in orthopaedic surgery |