| CTRI Number |
CTRI/2024/12/077750 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Functioning and X ray findings of fractured hip after replacing it by doing total hip replacement |
|
Scientific Title of Study
|
Functional and Radiological outcomes of Post acetabular fracture THR |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Likhith R Gowda |
| Designation |
Junior Resident |
| Affiliation |
KMC Manipal |
| Address |
C-805, Brigade Gateway, Brigade Gateway Road, Subramanyanagar 2nd Stage, Rajajinagar, Bengaluru, Karnataka 560055
Department of Orthopedics, Kasturba Hospital, KMC manipal,
Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
560055
India |
| Phone |
8494941306 |
| Fax |
|
| Email |
likhithgwd5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrath Raj BK |
| Designation |
Associate Professor |
| Affiliation |
KMC Manipal |
| Address |
Department of Orthopedics,
Kasturba hospital, KMC Manipal
Department of Orthopedics, Kasturba Hospital, KMC manipal,
Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7259695464 |
| Fax |
|
| Email |
Amrath.rajbk@Manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Likhith R Gowda |
| Designation |
Junior Resident |
| Affiliation |
KMC Manipal |
| Address |
C-805, Brigade Gateway, Brigade Gateway Road, Subramanyanagar 2nd Stage, Rajajinagar, Bengaluru, Karnataka 560055
Department of Orthopedics, Kasturba Hospital, KMC manipal,
Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
KARNATAKA
560055
India |
| Phone |
8494941306 |
| Fax |
|
| Email |
likhithgwd5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, KMC Manipal,
Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Likhith R Gowda |
| Address |
Department of Orthopedics,
Kasturba Hospital, KMC Manipal,
Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka-576104 |
| Type of Sponsor |
Other [Self sponspred] |
|
|
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 Likhith R Gowda |
Kasturba Hospital |
Room No 4, Department of Orthopedics,
Kasturba Hospital,
KMC Manipal,
Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
8494941306
likhithgwd5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba Hospital Institutional Ethics Committee - 2 (Student Resaerch) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with a history of acetabular fracture undergoing THA.
Adequate medical records and radiographic data available.
Patients should have undergone the surgery at least 1 year ago. |
|
| ExclusionCriteria |
| Details |
Patients with incomplete medical records or follow-up data.
Other significant hip pathologies.
Patients who did not adhere to physiotherapy as per unit protocol |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To look for the functional and radiological outcomes THR in patients with acetabular fracture |
1 year after the replacement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To look for the stability and how different types of fracture behave when THR is done |
1 year post operatively |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2024 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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 - NO
|
|
Brief Summary
|
The trial is to establish the various outcome of different patterns of fracture and differently managed fractures and how the outcomes would vary if THR is done in such patients |