| CTRI Number |
CTRI/2021/01/030690 [Registered on: 22/01/2021] Trial Registered Prospectively |
| Last Modified On: |
22/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Anterior cervical spine fusion study |
|
Scientific Title of Study
|
Comparison of anterior cervical fusion using Grafton ® vs local bone graft in Divergence ® interbody cage for cervical degenerative diseases - Randomized controlled trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Satish Rudrappa |
| Designation |
Director of Neurosciences and spine surgery |
| Affiliation |
Sakra World Hospital |
| Address |
Department of Neurosciences and Spine surgery, Sakra world hospital,
SY NO 52/2 and 52/3, Devarabeesanahalli, Varthur Hobli Opp Intel, Outer Ring Rd, Marathahalli, Bengaluru.
SY NO 52/2 and 52/3, Devarabeesanahalli, Varthur Hobli Opp Intel, Outer Ring Rd, Marathahalli, Bengaluru
Bangalore
KARNATAKA
560103
India |
| Phone |
9844020211 |
| Fax |
|
| Email |
drsatishr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Satish Rudrappa |
| Designation |
Director of Neurosciences and spine surgery |
| Affiliation |
Sakra World Hospital |
| Address |
Department of Neurosciences and Spine surgery, Sakra world hospital,
SY NO 52/2 and 52/3, Devarabeesanahalli, Varthur Hobli Opp Intel, Outer Ring Rd, Marathahalli, Bengaluru.
SY NO 52/2 and 52/3, Devarabeesanahalli, Varthur Hobli Opp Intel, Outer Ring Rd, Marathahalli, Bengaluru
Bangalore
KARNATAKA
560103
India |
| Phone |
9844020211 |
| Fax |
|
| Email |
drsatishr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Satish Rudrappa |
| Designation |
Director of Neurosciences and spine surgery |
| Affiliation |
Sakra World Hospital |
| Address |
Department of Neurosciences and Spine surgery, Sakra world hospital,
SY NO 52/2 and 52/3, Devarabeesanahalli, Varthur Hobli Opp Intel, Outer Ring Rd, Marathahalli, Bengaluru.
SY NO 52/2 and 52/3, Devarabeesanahalli, Varthur Hobli Opp Intel, Outer Ring Rd, Marathahalli, Bengaluru
Bangalore
KARNATAKA
560103
India |
| Phone |
9844020211 |
| Fax |
|
| Email |
drsatishr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sakra World Hospital,
SY NO 52/2 and 52/3, Devarabeesanahalli, Varthur Hobli Opp Intel, Outer Ring Rd, Marathahalli, Bengaluru 560103 |
|
|
Primary Sponsor
|
| Name |
Sakra World Hospital |
| Address |
SY NO 52/2 and 52/3, Devarabeesanahalli, Varthur Hobli Opp Intel, Outer Ring Rd, Marathahalli, Bengaluru 560103 |
| 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 |
| Satish Rudrappa |
Sakra World Hospital |
Department of Neurosciences and Spine surgery, SY NO 52/2 and 52/3, Devarabeesanahalli, Varthur Hobli Opp Intel, Outer Ring Rd, Marathahalli, Bengaluru 560103
Bangalore
KARNATAKA |
9844020211
drsatishr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-Sakra world Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M509||Cervical disc disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anterior cervical fusion |
Anterior cervical fusion is a surgery where the disc is removed and a cage is inserted to achieve union of two cervical bones |
| Comparator Agent |
Grafton and Local bone graft |
Grafton is a demineralized bone matrix which promotes bone fusion and this is compared with the local bone graft. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Degenerative disease of the cervical spine and
•Radiculopathy
•Myelopathy
•Kyphosis and disability
|
|
| ExclusionCriteria |
| Details |
•Infections / Trauma requiring ACDF
•ACDF Procedures combined with posterior surgeries
•Patients with more than 2 level pathology
•Severe medical co-morbidities precluding surgery
•Patients who have undergone surgery in Cervical region previously
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fusion |
Baseline,1,3,6,12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale (VAS) score pain assessment, mJOA (modified Japanese Orthopaedic Association) score, NDI (Neck disability index) and Odom’s criteria |
Baseline,1,3,6,12 months |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
27/01/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This academic study will be done at Sakra World Hospital. The patients (56) with degenerative cervical diseases and who fulfill the selection criteria will be randomized and will be grouped into Group A (28) - Grafton and Group B (28) - bone graft group. Both groups will be operated with Anterior cervical fusion surgeries with Divergence cage and the cage will be filled with Grafton - DBM in A group and local bone graft in B group. They will be analyzed and compared at 0,3,6,12 months both clinically and radiologically (Xray and CT). The clinical parameters that will be analyzed are m-JOA, VAS score for neck and radicular pain, Nuricks, Odoms criteria, and NDI. Radiologically they will be analyzed for fusion status and the time taken for fusion. The outcomes will be analyzed, compared and appropriate statistics will be applied for the interpretation of results |