| CTRI Number |
CTRI/2020/11/029072 [Registered on: 12/11/2020] 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 study to asses neurological and functional outcome after early surgical management of post traumatic dorsolumbar spine fracture |
|
Scientific Title of Study
|
A prospective study to asses neurological and functional outcome after early surgical management (decompression and fixation) of post traumatic dorsolumbar spine fracture with or without neurology from posterior instrumentation in Adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2020/10/SFNFO/AIOR Version 1.0 Dated 19 Oct 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pervez Anwar |
| 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 |
8863033237 |
| Fax |
|
| Email |
ppvzawr2k7@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 Pervez Anwar |
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 |
8863033237
ppvzawr2k7@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 |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of thoracolumbar spine injury having instability with or without neurological deficit and /or spinal canal compromise and compression on the spinal cord
2. Patients above the age of 18 years and above
3. Patients of either gender
4. Patients voluntarily willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Old untreated fractures
2. Patients with unstable clinical condition and abnormal biochemical profile
3. Patients with severe multi system injury (having major chest and abdominal trauma)
4. 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 early surgical management (decompression and fixation) of post-traumatic dorsolumbar spine fracture with or without neurology from posterior instrumentation in adults.
2) To evaluate the complications of early surgical management (decompression and fixation) of post traumatic dorsolumbar spine fracture with or without neurology from posterior instrumentation in adults
|
3 weeks, 6 weeks, 12 weeks and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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="2"
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 and complications of post traumatic dorsolumbar spine fracture with or without neurology from posterior instrumentation |