| CTRI Number |
CTRI/2020/11/029114 [Registered on: 13/11/2020] Trial Registered Prospectively |
| Last Modified On: |
11/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A prospective study to evaluate the Outcomes of managing Complex Supracondylar Fracture Humerus in Adults |
|
Scientific Title of Study
|
A prospective study to evaluate the post-Surgical management Outcomes of Complex Supracondylar Fracture Humerus in Adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2020/10/SFORIF/AIOR Version 1.0 Dated 08 Oct 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rishabh Kumar Singh |
| 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
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 |
8295243868 |
| Fax |
|
| Email |
orthosirius@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 Rishabh Kumar Singh |
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 |
8295243868
orthosirius@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: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with complex supracondylar fracture of the distal end of the humerus
2. Patients above the age of 18 years and less than 40 years
3. Patients of either gender
4. Patients being managed with open reduction and rigid internal fixation surgery
5. Patients willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Compound fractures of the distal humerus
2. Old fractures of the distal humerus
3. Patients who are hemodynamically unstable
4. polytrauma patients may benefit from provisional stabilization of the fracture instead of ORIF.
5. Infections and medical conditions that could pose a life-threatening surgical or anaesthetic risk are also contraindications.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To evaluate the functional outcome after surgical management of intercondylar fracture of distal humerus in adults by open reduction and rigid internal fixation.
2) To evaluate the advantages and complications of open reduction and rigid internal fixation procedures done for the intercondylar fracture of distal humerus in adults.
|
Post op, week 3, 6, 12 and Month 6 |
|
|
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 at present. Study yet to start |
|
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 of Open reduction and rigid internal fixation in patients with fracture of distal end of humerus. |