| CTRI Number |
CTRI/2013/12/004221 [Registered on: 17/12/2013] Trial Registered Retrospectively |
| Last Modified On: |
27/11/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
OUTCOME FOLLOWING CERVICAL FUSION SURGERY FOR CERVICAL DISC OR TRAUMA |
|
Scientific Title of Study
|
FUNCTIONAL OUTCOME OF CERVICAL FUSION IN CERVICAL DISC HERNIATION AND TRAUMA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR THOMAS DEVASIA |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ORTHOPAEDICS,
FATHER MULLER MEDICAL COLLEGE HOSPITAL, KANKANADY, MANGALORE - 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
|
| Fax |
|
| Email |
DRTHOMASDEVASIA@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JACOB CHACKO |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ORTHOPAEDICS,
FATHER MULLER MEDICAL COLLEGE HOSPITAL, KANKANADY, MANGALORE - 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
|
| Fax |
|
| Email |
CHACKOJAKES@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
DR JACOB CHACKO |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ORTHOPAEDICS,
FATHER MULLER MEDICAL COLLEGE HOSPITAL, KANKANADY, MANGALORE - 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
|
| Fax |
|
| Email |
CHACKOJAKES@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| FATHER MULLER MEDICAL COLLEGE HOSPITAL, MANGALORE - 575002 |
|
|
Primary Sponsor
|
| Name |
DR THOMAS DEVASIA |
| Address |
DEPARTMENT OF ORTHOPAEDICS,
FATHER MULLER MEDICAL COLLEGE HOSPITAL, MANGALORE - 575002 |
| Type of Sponsor |
Other [SELF] |
|
|
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 THOMAS DEVASIA |
ORTHOPAEDICS OPD 9 |
DEPARTMENT OF ORTHOPAEDICS,
FATHER MULLER MEDICAL COLLEGE HOSPITAL, KANKANADY, MANGALORE - 575002
Dakshina Kannada
KARNATAKA |
9535082191
DRTHOMASDEVASIA@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FATHER MULLER MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
CERVICAL DISC HERNIATION AND CERVICAL TRAUMA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ANTERIOR CERVICAL DECOMPRESSION AND FUSION |
STUDY FUNCTIONAL OUTCOME OF ANTERIOR CERVICAL DECOMPRESSION AND FUSION IN PATIENTS WITH CERVICAL TRAUMA OR CERVICAL DISC HERNIATION. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. 18 YEARS AND ABOVE INCLUDING BOTH SEXES
2. PATIENTS WITH TRAUMA TO CERVICAL SPINE OR CERVICAL DISC HERNIATION WITH NEUROLOGICAL DEFICITS WHO ARE WILLING FOR SURGERY AND FOLLOW UP. |
|
| ExclusionCriteria |
| Details |
1. PREVIOUS CERVICAL SURGERY
2. INFECTION, BONE DISEASE, NEOPLASM, PATHOLOGICAL FRACTURES.
3. SPINAL ANOMALIES.
4. MENTAL OR PSYCHIATRIC DISORDER
5. SEVERE OSTEOPOROSIS
6. SERIOUS CO-MORBID CONDITIONS PRECLUDING SURGICAL INTERVENTION IN THESE TYPES OF CASES.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| REDUCTION OF PAIN AND IMPROVEMENT IN NEUROLOGY. |
IMMEDIATE POST OPERATIVE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IMPROVEMENT IN NEUROLOGICAL OUTCOME AND FUNCTION FOLLOWING ANTERIOR CERVICAL DECOMPRESSION AND FUSION. |
POST-OPERATIVE AT 6 WEEKS, 3 MONTHS, 6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
07/10/2011 |
| 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) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is intended to observe the role of cervical fusion with anterior cervical decompression in cases of cervical disc herniation and in cases of trauma, its effects on cervical mobility, complications and the neurological improvement. A sample size of minimum 25 patients will be selected using purposive sampling technique, all of whom will undergo cervical decompression surgery followed with cervical fusion. Clinical and radiological improvement will be studied during follow up at 6 weeks, 3 months and 6 months. |