| CTRI Number |
CTRI/2020/08/027343 [Registered on: 24/08/2020] Trial Registered Prospectively |
| Last Modified On: |
21/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [percutaneous vertebroplasty] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of percutaneous vertebroplasty in patients with osteoporotic vertebral compression fracture. |
|
Scientific Title of Study
|
Prospective evaluation of percutaneous vertebroplasty in osteoporotic vertebral compression fracture patients. |
| Trial Acronym |
OPVCF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr shivani rastogi |
| Designation |
Associate professor |
| Affiliation |
Dr.RMLIMS |
| Address |
Dr. RMLIMS
Department of anesthesia
Gomti nagar
Lucknow
Department of anesthesia,
Dr.RMLIMS
Lucknow
Lucknow
UTTAR PRADESH
221060
India |
| Phone |
8176007201 |
| Fax |
|
| Email |
neuromanu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shivani rastogi |
| Designation |
associate professor |
| Affiliation |
Dr.RMLIMS |
| Address |
Dr. RMLIMS
Department of anesthesia
Gomti nagar
Lucknow
Department of anesthesia,
Dr.RMLIMS
Lucknow
UTTAR PRADESH
221060
India |
| Phone |
8176007201 |
| Fax |
|
| Email |
neuromanu@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr yasum litin |
| Designation |
junior resident |
| Affiliation |
Dr.RMLIMS |
| Address |
Dr. RMLIMS
Department of anesthesia
Gomti nagar
Lucknow
Dr. RMLIMS
Department of anesthesia
Gomti nagar
Lucknow
Lucknow
UTTAR PRADESH
221060
India |
| Phone |
7005864830 |
| Fax |
|
| Email |
yasumlitin21@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrShivani Rastogi |
| Address |
Dr.RMLIMS |
| Type of Sponsor |
Government medical college |
|
|
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 shivani rastogi |
pain opd |
Dr. RMLIMS
Department of anesthesia
Gomti nagar
Lucknow
Lucknow
UTTAR PRADESH |
8176007120
neuromanu@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.RMLIMS Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M800||Age-related osteoporosis with current pathological fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
percutaneous vertebroplasty |
fluoroscopic guidance percutaneous vertebroplasty with polymethyl methacrylayte bone cement |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
-1-3 painful OVCF at any levels with a physical examination and radiographic findings
-patients with chronic back pain ( > 12 weeks )not responding to primary treatment.
-coagulation test should be normal. |
|
| ExclusionCriteria |
| Details |
-pedicle fracture
-cord compression
-patients refusal to give consent
-local or systemic infection
-concomitant hip fractures
-osteoporotic vertebral collapse > 90 %
-previous vertebroplasty
-posterior vertebral body breach
-significant compromise of spinal canal by retropulsed bone fragment or tumor
-pregnant patients
-vertebral compression fracturea patients with multiple myeloma and metstatic tumors
- patient with known coagulopathy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain relief following percutaneous vertebroplasty. |
follow up at 1 week , 1 month, 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in vertebral height, wedge angle, corelation of pain relief with percentage of correction |
follow up at 1 week , 1 month, 6th month |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
26/08/2020 |
| 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="6"
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)?
|
|
Brief Summary
|
osteoporotic vertebral compression fracture is a leading cause of disability and morbidity in the elderly. percutaneous vertebroplasty is a minimally invasive procedure providing better pain relief and avoid major surgeries. |