| CTRI Number |
CTRI/2025/10/096519 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing shoulder stability and function after using one anchor versus two anchors in surgery for shoulder dislocations |
|
Scientific Title of Study
|
Assessment of Functional outcomes and re dislocation rate after single anchor versus double anchor configuration in Arthroscopic Remplissage and Bankart Repair |
| 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 Aman Yadav |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Orthopaedic Surgery,Counter No.15,Nehru Hospital,PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8527547560 |
| Fax |
|
| Email |
01.amanydv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharad Prabhakar |
| Designation |
Proffessor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Orthopaedic Surgery,Counter No.15,Nehru Hospital,PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9781716119 |
| Fax |
|
| Email |
sharad.ortho@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aman Yadav |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Orthopaedic Surgery,Counter No.15,Nehru Hospital,PGIMER
CHANDIGARH
160012
India |
| Phone |
8527547560 |
| Fax |
|
| Email |
01.amanydv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedic Surgery,Counter No.15,Nehru Hospital,PGIMER,Chandigarh-160012,India |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education & Research, Chandigarh |
| Address |
Madhya Marg, Sector 12, Chandigarh, 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Aman Yadav |
Post Graduate Institute of Medical Educatiopn and Reseach |
Department of Orthopaedic Surgery,Counter No.15,Nehru Hospital
Chandigarh
CHANDIGARH |
08527547560
01.amanydv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Intramural |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Double Anchor Group |
Two Suture anchor will be placed in humeral head defect and then results will be compared and follow up will be done at 6 weeks , 3 months and 6 months |
| Intervention |
Single Anchor Group |
Single suture anchor will be placed in Humeral head defect and then results will be compared and follow uo will be done at 6 weeks , 3 months and 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All skeletally mature adults of either sex ,aged 18 to 75 years with recurrent anterior shoulder instability. |
|
| ExclusionCriteria |
| Details |
1)Arthritis of Shoulder joint (Osteoarthritis, Rheumatoid arthritis, septic arthritis)
2)Bilateral recurrent shoulder dislocation
3)Shoulder instability because of an irreparable cuff tear
4)Habitual shoulder dislocation
5)Any patient who withholds consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1- ASES-American shoulder and Elbow surgeons score
2-Rowe Score
3-Constant Murley Score |
3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare external rotation |
6 weeks, 3months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
11/11/2025 |
| 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="4"
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
|
Patient presents to Orthopaedic OPD,PGIMER. The patients will be assessed for duration of instability, details of first dislocation including trauma, time to reduction, period of immobilisation, rehabilitation, time to second dislocation, Total no. of dislocations, present difficulty in activities of daily living. Clinical tests will be perfomed- Apprehension test, Sulcus test and Anterior Drawer test. Inclusion and exclusion criterias will be checked. Radiological Study will also be done- XRAY,CT and MRI -Humeral head defect and Glenoid defect will be calculated.Once patient gets admitted for the surgery, his/her data will be entered to our database and the group will be allotted for him based on the number he is at, in our study from the block randomisation generated using computer generated randomisation. Randomisation will bedone for using single anchor vs double anchor configuration in Arthroscopic Remplissage and Bankart Repair.There will be a Rehabilitation Programme. Primary outcome variable will be compared - ASES, Rowe Score and Constant Murley score at 3 months and 6 months and secondary outcome variables. so we will do assessment of Functional outcomes and re-dislocation rate after single anchor vs double anchor configuration in Arthroscopic Remplissage and Bankart Repair. |