| CTRI Number |
CTRI/2021/01/030336 [Registered on: 08/01/2021] Trial Registered Prospectively |
| Last Modified On: |
07/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Dual Mobility Cup THR VS Conventional Total Hip Replacement for Fracture Neck Of Femur |
|
Scientific Title of Study
|
Comparision between Dual Mobility Cup and Conventional Total Hip Replacement for Fracture Neck Of Femur |
| Trial Acronym |
DMC THR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR YESHWANTH |
| Designation |
CLINICAL FELLOW |
| Affiliation |
SUNSHINE HOSPITAL |
| Address |
ORTHOPAEDICS DEPARTMENT
SUNSHINE HOSPITALS
PG ROAD
SECUNDERABAD
Hyderabad
TELANGANA
500003
India |
| Phone |
8008500345 |
| Fax |
|
| Email |
DR.YESHWANTH.N@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR YESHWANTH |
| Designation |
CLINICAL FELLOW |
| Affiliation |
SUNSHINE HOSPITAL |
| Address |
ORTHOPAEDICS DEPARTMENT
SUNSHINE HOSPITALS
PG ROAD
SECUNDERABAD
Hyderabad
TELANGANA
500003
India |
| Phone |
8008500345 |
| Fax |
|
| Email |
DR.YESHWANTH.N@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
DR YESHWANTH |
| Designation |
CLINICAL FELLOW |
| Affiliation |
SUNSHINE HOSPITAL |
| Address |
ORTHOPAEDICS DEPARTMENT
SUNSHINE HOSPITALS
PG ROAD
SECUNDERABAD
Hyderabad
TELANGANA
500003
India |
| Phone |
8008500345 |
| Fax |
|
| Email |
DR.YESHWANTH.N@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SUNSHINE HOSPITAL |
| Address |
SUNSHINE HOSPITAL, PG ROAD,NEAR PARADISE, HYDERABAD |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Ratnakar |
Sunshine Hospital |
ORTHOPAEDICS DEPARTMENT
SUNSHINE HOSPITALS
PG ROAD
SECUNDERABAD
Hyderabad
TELANGANA |
9544638861
Ratnakar.vecham@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sunshine hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S720||Fracture of head and neck of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional THR |
Conventional Cup |
| Comparator Agent |
Dual mobillity THR |
Dual cup |
| Intervention |
Dual mobillity vs Conventional THR |
THR |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ALL NECK OF FEMUR FRACTURES REQUIRING TOTAL HIP REPLACEMENT IRRESPECTIVE OF AGE |
|
| ExclusionCriteria |
| Details |
Other Revisions and IT fractures |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Functional outcome |
Functional outcome |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rate of dislocations |
NA |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
11/01/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Total hip arthroplasty is regularly performed in patients with a femoral neck fracture. However, dislocation is common after THA in hip fracture patients, and this complication is deleterious to quality of life. The dual mobility cup offers a technical solution that potentially reduces the risk of dislocation.There is however no high-level evidence to support the general use of dual mobility cups in patients with displaced femoral neck fractures and the purpose of the proposed study is to provide evidence to support or refute the use of this concept in Neck of Femur fracture patients.
AIMS AND OBJECTIVES
1.EVALUATING THE FUNCTIONAL OUTCOME OF PATIENTS UNDERGOING TOTAL HIP REPLACEMENT WITH CONVENTIONAL TOTAL HIP REPLACEMENT AND DUAL MOBILITY CUP IN FRACTURE NECK OF FEMUR
2.COMPARING THE COMPLICATIONS AND DISLOCATION RATES IN THE TWO GROUPS.
PATIENTS AND METHODS
Source of data
The proposed study is a hospital-based prospective study centred in Sunshine Hospitals, Secunderabad and Gachibowli.
Study design
The study will be a prospective, Non-Time-bound hospital-based , randomized study. Cases satisfying the inclusion criteria admitted in Sunshine Hospitals during the study period from August 2019 till sample size criteria is met. Patients will be followed for a period of 6 months to 1 year and evaluated clinically with Harris hip score. Scores and outcome will be used for evaluation.
Sample Size: 50 ( 25 in each group) |