| CTRI Number |
CTRI/2023/12/060688 [Registered on: 22/12/2023] Trial Registered Prospectively |
| Last Modified On: |
18/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Multicenter study for outcomes of stabilization surgery in unstable shoulder |
|
Scientific Title of Study
|
Prospective multicenter study for determining the functional outcomes after surgical stabilization for unstable shoulder |
| 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. Dipit Sahu |
| Designation |
Consultant shoulder surgeon |
| Affiliation |
Bharatratna Dr. Babasaheb Ambedkar Memorial Hospital, Byculla, Mumbai 400027 |
| Address |
Galleria Shopping Mall, B wing , Room no. 407, Central Ave, Hiranandani Gardens, Powai, Mumbai, Maharashtra 400076
Powai
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
09619136962 |
| Fax |
|
| Email |
dip.it@me.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Dipit Sahu |
| Designation |
Consultant shoulder surgeon |
| Affiliation |
Bharatratna Dr. Babasaheb Ambedkar Memorial Hospital, Byculla, Mumbai 400027 |
| Address |
Galleria Shopping Mall, B wing , Room no. 407, Central Ave, Hiranandani Gardens, Powai, Mumbai, Maharashtra 400076
Powai
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
09619136962 |
| Fax |
|
| Email |
dip.it@me.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Dipit Sahu |
| Designation |
Consultant shoulder surgeon |
| Affiliation |
Bharatratna Dr. Babasaheb Ambedkar Memorial Hospital, Byculla, Mumbai 400027 |
| Address |
Galleria Shopping Mall, B wing , Room no. 407, Central Ave, Hiranandani Gardens, Powai, Mumbai, Maharashtra 400076
Powai
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
09619136962 |
| Fax |
|
| Email |
dip.it@me.com |
|
|
Source of Monetary or Material Support
|
| Bharatratna Dr. Babasaheb Ambedkar Memorial Hospital, Byculla, Mumbai 400027 and Mumbai Shoulder Institute, Powai, Hiranandani, Mumbai 400076 |
|
|
Primary Sponsor
|
| Name |
Dipit Sahu |
| Address |
Galleria Shopping Mall, B wing , Room no. 407, Central Ave, Hiranandani Gardens, Powai, Mumbai, Maharashtra 400076 |
| Type of Sponsor |
Other [Private Clinic] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dipit Sahu |
Bharatratna Dr. Babasaheb Ambedkar Memorial Hospital |
Department of Orthopaedics, Room no. 109, Byculla east, mumbai 400027
Mumbai
MAHARASHTRA |
9922223900
dip.it@me.com |
| Vivek Pandey |
Kasturba Medical College |
Room no. 1, Department of Orthopaedics, Kasturba Medical College, KMC Manipal Academy of Higher Education, Manipal, Udupi, Karnataka
Mumbai
MAHARASHTRA |
89715643113
vivekortho@gmail.com |
| Nilesh Kamat |
Sancheti Hospital |
Department of Orthopaedics 11/12 Thube Park, 16, 16, Shivajinagar, Pune, Maharashtra 411005
Pune
MAHARASHTRA |
9922223900
nileshkamat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Bharatratna Dr. Babasaheb Ambedkar Memorial Hospital Ethics Committee |
Approved |
| Institutional Ethics Committee, KMC Manipal |
Submittted/Under Review |
| Sancheti hospital Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M244||Recurrent dislocation of joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Anterior shoulder instability (>1 dislocation / subluxation)
< 15% anteroposterior glenoid bone loss
With or without hyperlaxity
|
|
| ExclusionCriteria |
| Details |
•significant shoulder comorbidities (i.e., osteoarthritis, previous shoulder surgery)
•active joint or systemic infection, significant muscle paralysis, rotator cuff tears
•significant medical comorbidity that may alter effectiveness of surgical intervention
•psychiatric illness that precludes informed consent,
•unwilling to be followed for 2 years
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Oxford shoulder instability score
Rowe score
|
main 2-year follow-up and also at 6 months, 1-year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Range of motion (ROM): (also 6-month & 12-month)
Recurrence of dislocation or subluxation
Residual pain
Return to sports
Complications (infection / nerve damage / implant failure / stiffness)
Revision surgery due to any cause
|
2-year follow-up |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/01/2024 |
| 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="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dip.it@me.com].
- For how long will this data be available start date provided 01-01-2024 and end date provided 01-01-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The study will start recruiting patients in 3 months time, the first patient will be operated as per the protocol and further consecutive patients will be enrolled after that |