| CTRI Number |
CTRI/2024/08/071953 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
26/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
study of shoulder dislocation and bone loss by CT scan and MRI |
|
Scientific Title of Study
|
assessment of bone loss in patient with anterior glenohumeral instability using MRI shoulder 3D sequence V/S 3D CT shoulder at GMC and Sir T General Hospital Bhavnagar |
| 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 Sarju Patel |
| Designation |
1st year resident |
| Affiliation |
Government medical college and Sir Takhtasinji general hospital |
| Address |
Radiodiagnosis department, Government medical college, Sir Takhtasinhji general hospital.
Bhavnagar
GUJARAT
364001
India |
| Phone |
08866730215 |
| Fax |
|
| Email |
sarjupatel89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vipul Solanki |
| Designation |
Associate Professor |
| Affiliation |
Government medical college and Sir Takhtasinji general hospital |
| Address |
Radiodiagnosis department, Government medical college, Sir Takhtasinhji general hospital.
Bhavnagar
GUJARAT
364001
India |
| Phone |
8866730215 |
| Fax |
|
| Email |
virbapu1989@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarju Patel |
| Designation |
1st year resident |
| Affiliation |
Government medical college and Sir Takhtasinji general hospital |
| Address |
Radiodiagnosis department, Government medical college, Sir Takhtasinhji general hospital.
Bhavnagar
GUJARAT
364001
India |
| Phone |
8866730215 |
| Fax |
|
| Email |
sarjupatel89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Takhtasinhji general hospital, Bhavnagar, Gujarat, India- 364001 |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [Routine investigation] |
|
|
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 Sarju Patel |
Sir Takhtasinhji general hospital |
Radiodiagnosis department, Sir Takhtasinhji general hospital.
Bhavnagar
GUJARAT |
8866730215
sarjupatel89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee Govt medical college bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S430||Subluxation and dislocation of shoulder joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients with anterior shoulder dislocation presented for CT and MRI Imaging |
|
| ExclusionCriteria |
| Details |
OPERATED CASE OF INSTABILITY WITH RECURRENT DISLOCATION AND PATIENTS WITH IMPLANT OR STENT INSERTION |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glenoid bone loss in CT and MRI and Hill Sachs lesion in CT and MRI |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
comparison of Glenoid bone loss in CT & MRI.
comparison of Hill Sachs lesion in CT & MRI |
baseline |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
15/08/2024 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
CT scan and MRI - shoulder will be done in all case of recurrent anterior shoulder dislocation. The glenoid bone loss, size of Hill-Sachs lesion are important while deciding operative management versus conservative management. The CT shoulder examination is fast but still has added economic and radiation impact to patient. The availability of 3 T MRI and new pulse sequences like 3D VIBE can demonstrate bone morphology, bone loss and soft tissue also. The purpose of this study is to evaluate the reliability of standard radiographs- MRI, CT and predicting the true amount of glenoid bone loss with each modality and to reduce the expense and radiation burden to the patient. |