| CTRI Number |
CTRI/2020/11/029022 [Registered on: 10/11/2020] Trial Registered Prospectively |
| Last Modified On: |
09/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to evaluate the functional outcome after Surgical management of fractures of neck of femur in young adults |
|
Scientific Title of Study
|
Prospective study to evaluate the functional outcome after Surgical management of Intracapsular Neck of Femur Fractures in young adults managed with Hip bolt and Strut Fibular graft |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2020/10/SFHBFG/AIOR Version 1.0 Dated 07 Oct 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arun Jayaraj |
| Designation |
Senior Resident |
| Affiliation |
Anup Institute of Orthopedics and Rehabilitation |
| Address |
R. NO. 117, Ground Floor, AIOR OPD complex, Anup Institute of Orthopedics and Rehabilitation, (AIOR)
G 75, 77, P C Colony Rd, Kankarbagh, Bankman Colony, Patna, Bihar 800020, India
Patna
BIHAR
800020
India |
| Phone |
8075861735 |
| Fax |
|
| Email |
drarunjayaraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Singh |
| Designation |
Consultant Orthopedic Surgeon and Director |
| Affiliation |
Anup Institute of Orthopedics and Rehabilitation |
| Address |
R. NO. 117, Ground Floor, AIOR OPD complex, Anup Institute of Orthopedics and Rehabilitation, (AIOR)
G 75, 77, P C Colony Rd, Kankarbagh, Bankman Colony, Patna, Bihar 800020, India
Patna
BIHAR
800020
India |
| Phone |
8294240349 |
| Fax |
|
| Email |
drashishsingh@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Singh |
| Designation |
Consultant Orthopedic Surgeon and Director |
| Affiliation |
Anup Institute of Orthopedics and Rehabilitation |
| Address |
R. NO. 117, Ground Floor, AIOR OPD complex, Anup Institute of Orthopedics and Rehabilitation, (AIOR)
G 75, 77, P C Colony Rd, Kankarbagh, Bankman Colony, Patna, Bihar 800020, India
Patna
BIHAR
800020
India |
| Phone |
8294240349 |
| Fax |
|
| Email |
drashishsingh@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Anup Institute of Orthopedics and Rehabilitation |
|
|
Primary Sponsor
|
| Name |
Anup Institute of Orthopedics and Rehabilitation |
| Address |
Anup Institute of Orthopedics and Rehabilitation, (AIOR)
G 75, 77, P C Colony Rd, Kankarbagh, Bankman Colony, Patna, Bihar 800020, India
|
| 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 Arun Jayaraj |
Anup Institute of Orthopedics and Rehabilitation |
R. NO. 117, Ground Floor, AIOR OPD complex, Anup Institute of Orthopedics and Rehabilitation, (AIOR)
G 75, 77, P C Colony Rd, Kankarbagh, Bankman Colony, Patna, Bihar 800020, India
Patna
BIHAR |
8075861735
drarunjayaraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Anup Institute of Orthopedics and Rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Intracapsular fracture neck of femur due to trauma
2. Age group: 20 to 50
3. Fresh/ recent fractures
4. Agreed on voluntary informed Consent
|
|
| ExclusionCriteria |
| Details |
1. Pathological fracture
2. Neglected fractures
3. Associated autoimmune/connective tissue disorders
4. Medically unfit for surgery
5. Patient refusing for surgery
6. Patients with diabetes mellitus, infection around surgical site
7. Evidence of sequalae of septic arthritis or avascular necrosis
8. Previous history of any surgery around affected joint, polytrauma and fractures those requiring open reduction were excluded from the study.
9. Comatose |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post-surgical functional outcome will be assessed by Harris hip score.
In addition, Hip pain, range of hip motion, evidence of bone union, presence of avascular necrosis, graft incorporation, and position of the screws/graft will be assessed.
|
6, 12, 18 and 24 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
16/11/2020 |
| 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
|
Single-center, prospective, observational study to assess the functional outcomes, complications in patients undergoing surgical management for intracapsular fractures of neck of femur.
|