| CTRI Number |
CTRI/2017/10/010221 [Registered on: 27/10/2017] Trial Registered Prospectively |
| Last Modified On: |
25/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Analysis of Surgery results in repeat slippage of disc occuring again after 1st surgery. |
|
Scientific Title of Study
|
A retrospective analysis of clinical and radiological outcome in Recurrent Disc Prolapse. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDDevanand |
| Designation |
Principal Investigator and Consultant Spine Surgeon |
| Affiliation |
Stavya Spine Hospital and Research Institute |
| Address |
Stavya Spine Hospital and Research Institute
Nr Nagari Hospital
Mithakhali
Ellisbridge
Ahmedabad
Ahmadabad
GUJARAT
380006
India |
| Phone |
07874444091 |
| Fax |
|
| Email |
drdanand@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDDevanand |
| Designation |
Principal Investigator and Consultant Spine Surgeon |
| Affiliation |
Stavya Spine Hospital and Research Institute |
| Address |
Stavya Spine Hospital and Research Institute
Nr Nagari Hospital
Mithakhali
Ellisbridge
Ahmedabad
Ahmadabad
GUJARAT
380006
India |
| Phone |
07874444091 |
| Fax |
|
| Email |
drdanand@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DrDenish Patel |
| Designation |
Co-Investigator and Consultant Spine Surgeon |
| Affiliation |
Stavya Spine Hospital and Research Institute |
| Address |
Stavya Spine Hospital and Research Institute
Nr Nagari Hospital
Mithakhali
Ellisbridge
Ahmedabad
Ahmadabad
GUJARAT
380006
India |
| Phone |
09925954948 |
| Fax |
|
| Email |
drdenishpatel@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Stavya Spine Hospital and Research Institute |
| Address |
Nr Nagari Hospital
Mithakhali
Ellisbridge
Ahmedabad |
| Type of Sponsor |
Research institution and hospital |
|
|
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 D Devanand |
Stavya Spine Hospital and Research Institute |
Spine Research Wing
Nr Nagari Hospital
Mithakhali
Ellisbridge
Ahmedabad 380006
India
Ahmadabad
GUJARAT |
07874444091
drdanand@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Stavya Spine Hospital and Research Institute Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Recurrent Disc Prolapse , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.Age : 25 – 85 yrs , Male or Female
2.Single level Lumbosacral fusion L4-5 or L5-S1
operated by conventional posterior
approach for recurrent disc.
3.Psychosocially, mentally and physically able
to fully comply with this protocol
including adhering to completing forms and
other study procedures.
4.Personally signed and dated informed consent
document prior to any study-related
procedures indicating that the patient has
been informed of all pertinent aspects of
the study.
|
|
| ExclusionCriteria |
| Details |
1.Redo discectomy
2.Lumbar infection.
3.Lumbar laminectomy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 ODI and VAS Scores
2 X-Rays of L S Spine AP and
Lateral |
12 - 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 ODI and VAS Scores
2 X-Rays of L S Spine AP and
Lateral |
24 - 36 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="89" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/11/2017 |
| Date of Study Completion (India) |
31/08/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a retrospective analysis of 100 patients who have undergone surgery for recurrence of Lumbar Disc Prolapse. Patients who met all inclusion/exclusion criteria will be enrolled in the study. Patients will be evaluated for clinical outcome by recording Oswestry Disability Index (ODI) Score and Visual Analogue Scores (VAS) and radiological outcome using X-Rays of L.S.Spine at the final follow up , after primary surgery by lumbar fusion at our center. |