| CTRI Number |
CTRI/2020/09/027830 [Registered on: 16/09/2020] Trial Registered Prospectively |
| Last Modified On: |
14/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
comparison of outcome in function and structure (as seen in xrays) of posterior decompression versus posterior decompression and fixation ( by using metallic implants in spine)in patents of cervical spondylotic myelopathy affected at multiple levels |
|
Scientific Title of Study
|
Clinico-radiological outcome of Posterior decompression vs Posterior decompression and
Lateral mass screw fixation in multisegmental Cervical Spondylotic Myelopathy: randomized control study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarvdeep Singh Dhatt |
| Designation |
Additional Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Orthopaedics, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008477 |
| Fax |
|
| Email |
sdhatt@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balwinder Sherry |
| Designation |
Junior Resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Orthopaedics, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
6280831142 |
| Fax |
|
| Email |
balwindersherry@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balwinder Sherry |
| Designation |
Junior Resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Orthopaedics, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
6280831142 |
| Fax |
|
| Email |
balwindersherry@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedics, PGIMER, Chandigarh, 160012 |
|
|
Primary Sponsor
|
| Name |
Dr Balwinder Sherry |
| Address |
Department of Orthopaedics, PGIMER, Chandigarh, 160012 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sarvdeep Singh Dhatt |
Department of Orthopaedics, PGIMER, Chandigarh, 160012 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Balwinder Sherry |
PGIMER |
Department of Orthopaedics
Chandigarh
CHANDIGARH |
6280831142
balwindersherry@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M471||Other spondylosis with myelopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lateral Mass Screw fixation and
posterior decompression. |
In one group Lateral Mass screws will be inserted after Posterior decompression.
Frequency/ Duration : This is a one time surgical procedure. Repeat surgery is not expected in this study. |
| Comparator Agent |
Posterior Decompression |
In one group only posterior decompression will be done.
Frequency/ Duration : This is a one time surgical procedure. Repeat surgery is not expected in this study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Symptomatic Multisegmental Cervical Spondylotic Myelopathy
2. Glasgow coma scale 15/15
3. Giving consent and fit in pre anaesthetic checkup |
|
| ExclusionCriteria |
| Details |
1. Age less than 18
2. Prior cervical spine surgery
3. Myelopathy due to non degenerative cause.
4. Kyphotic alignment of cervical spine or straightened cervical curve
5. History of severe bleeding, coagulopathy, thrombocytopenia
6. Patients intubated/sedated prior to neurological examination
7. patients not willing to participate in study/ not giving consent
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical outcome assessed by mJOA scoring and recovery rate |
day of admission, day of surgery, 2 weeks, 6 weeks, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| radiological outcome |
3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
21/09/2020 |
| 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)?
Response - NO
|
|
Brief Summary
|
This study is a randomised control trial to compare clinical and radiological outcome of posterior decompression vs posterior decompression and lateral mass screw fixation in patients with multisegmental Cervical spondylotic Myelopathy. Patients will be followed for a period of 6 months and at each followup mJOA score and recovery rate will be calculated. For radiological outcome xrays will be done on followup at 3rd and 6th month after surgery |